Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

Cybersecurity in Medical Devices:

Quality System Considerations and

Content of Premarket Submissions

Guidance for Industry and

Food and Drug Administration Staff

Document issued on September 27, 2023.

The draft of this document was issued on April 8, 2022.

This document supersedes “Content of Premarket Submissions for

Management of Cybersecurity in Medical Devices,” issued October 2, 2014.

For questions about this document regarding CDRH-regulated devices, contact

[email protected]. For questions about this document regarding CBER-regulated devices,

contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or

240-402-8010, or by email at [email protected].

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Center for Biologics Evaluation and Research

Contains Nonbinding Recommendations

Preface

Public Comment

You may submit electronic comments and suggestions at any time for Agency consideration to

https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food

and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.

Identify all comments with the docket number FDA-2021-D-1158. Comments may not be acted

upon by the Agency until the document is next revised or updated.

Additional Copies

CDRH

Additional copies are available from the Internet. You may also send an email request to

CDRH[email protected] to receive a copy of the guidance. Please include the document

number GUI00001825 and complete title of the guidance in the request.

CBER

Additional copies are available from the Center for Biologics Evaluation and Research (CBER),

Office of Communication, Outreach, and Development (OCOD), 10903 New Hampshire Ave.,

WO71, Room 3128, Silver Spring, MD 20903, or by calling 1-800-835-4709 or 240-402-8010,

by email, [email protected], or from the Internet at

https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-

biologics/biologics-guidances

Contains Nonbinding Recommendations

Table of Contents

I. Introduction ............................................................................................................................. 1

II. Scope ....................................................................................................................................... 2

III. Background ............................................................................................................................. 3

IV. General Principles ................................................................................................................... 5

A. Cybersecurity is Part of Device Safety and the Quality System Regulation ................... 5

1. A Secure Product Development Framework (SPDF) may be one way to satisfy the

QS regulation .......................................................................................................................... 6

B. Designing for Security ..................................................................................................... 7

C. Transparency .................................................................................................................... 8

D. Submission Documentation.............................................................................................. 8

V. Using an SPDF to Manage Cybersecurity Risks .................................................................. 10

A. Security Risk Management ............................................................................................ 11

1. Threat Modeling ......................................................................................................... 13

2. Cybersecurity Risk Assessment ................................................................................. 14

3. Interoperability Considerations .................................................................................. 15

4. Third-Party Software Components ............................................................................. 15

5. Security Assessment of Unresolved Anomalies ......................................................... 18

6. TPLC Security Risk Management .............................................................................. 19

B. Security Architecture ...................................................................................................... 20

1. Implementation of Security Controls ......................................................................... 21

2. Security Architecture Views ....................................................................................... 23

C. Cybersecurity Testing .................................................................................................... 26

VI. Cybersecurity Transparency ................................................................................................. 28

A. Labeling Recommendations for Devices with Cybersecurity Risks .............................. 28

B. Cybersecurity Management Plans .................................................................................. 30

Appendix 1. Security Control Categories and Associated Recommendations ............................. 32

Authentication ................................................................................................................ 32

Authorization .................................................................................................................. 34

Cryptography .................................................................................................................. 35

Code, Data, and Execution Integrity .............................................................................. 36

Confidentiality ................................................................................................................ 37

Event Detection and Logging ......................................................................................... 37

Contains Nonbinding Recommendations

Resiliency and Recovery ................................................................................................ 39

Firmware and Software Updates .................................................................................... 39

Appendix 2. Submission Documentation for Security Architecture Flows .................................. 41

A. Diagrams ........................................................................................................................ 41

B. Information Details for an Architecture View ............................................................... 41

Appendix 3. Submission Documentation for Investigational Device Exemptions....................... 44

Appendix 4. General Premarket Submission Documentation Elements and Scaling with Risk .. 45

Appendix 5. Terminology ............................................................................................................. 48

Contains Nonbinding Recommendations

Cybersecurity in Medical Devices:

Quality System Considerations and

Content of Premarket Submissions

Guidance for Industry and

Food and Drug Administration Staff

This guidance represents the current thinking of the Food and Drug Administration (FDA or

Agency) on this topic. It does not establish any rights for any person and is not binding on

FDA or the public. You can use an alternative approach if it satisfies the requirements of the

applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff

or Office responsible for this guidance as listed on the title page.

I. Introduction

With the increasing integration of wireless, Internet- and network-connected capabilities,

portable media (e.g., USB or CD), and the frequent electronic exchange of medical device-

related health information and other information, the need for robust cybersecurity controls to

ensure medical device safety and effectiveness has become more important.

In addition, cybersecurity threats to the healthcare sector have become more frequent and more

severe, carrying increased potential for clinical impact. Cybersecurity incidents have rendered

medical devices and hospital networks inoperable, disrupting the delivery of patient care across

healthcare facilities in the U.S. and globally. Such cyber attacks and exploits may lead to patient

harm as a result of clinical hazards, such as delay in diagnoses and/or treatment.

Increased connectivity has resulted in individual devices operating as single elements of larger

medical device systems. These systems can include healthcare facility networks, other devices,

and software update servers, among other interconnected components. Consequently, without

adequate cybersecurity considerations across all aspects of these systems, a cybersecurity threat

can compromise the safety and/or effectiveness of a device by compromising the functionality of

any asset in the system. As a result, ensuring device safety and effectiveness includes adequate

device cybersecurity, as well as its security as part of the larger system.

For the current edition of the FDA-recognized consensus standard(s) referenced in this

document, see the FDA Recognized Consensus Standards Database.

For more information

Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm

Contains Nonbinding Recommendations

regarding use of consensus standards in regulatory submissions, please refer to the FDA

guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions

for Medical Devices”

and “Standards Development and the Use of Standards in Regulatory

Submissions Reviewed in the Center for Biologics Evaluation and Research.”

For applications currently pending with FDA at the time of initial publication of this guidance, as

well as those submitted after initial publication of this guidance, FDA intends to work

collaboratively with manufacturers of such premarket submissions as part of the FDA review

process.

In general, FDA’s guidance documents do not establish legally enforceable responsibilities.

Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only

as recommendations, unless specific regulatory or statutory requirements are cited. The use of

the word should in Agency guidances means that something is suggested or recommended, but

not required.

II. Scope

This guidance document is applicable to devices with cybersecurity considerations, including but

not limited to devices that have a device software function

or that contain software (including

firmware) or programmable logic. The guidance is not limited to devices that are network-enabled

or contain other connected capabilities. This guidance describes recommendations regarding the

cybersecurity information to be submitted for devices under the following premarket submission

types, when submitted to the Center for Devices and Radiological Health (CDRH) or the Center

for Biologics Evaluation and Research (CBER):

• Premarket Notification (510(k)) submissions;

• De Novo requests;

• Premarket Approval Applications (PMAs) and PMA supplements;

• Product Development Protocols (PDPs);

• Investigational Device Exemption (IDE) submissions;

• Humanitarian Device Exemption (HDE) submissions;

• Biologics License Application (BLA) submissions; and

• Investigational New Drug (IND) submissions.

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-

voluntary-consensus-standards-premarket-submissions-medical-devices

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/standards-development-

and-use-standards-regulatory-submissions-reviewed-center-biologics-evaluation

For the purposes of this guidance, “device software function” means software function that meets the device

definition in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The term “function” is a

distinct purpose of the product, which could be the intended use or a subset of the intended use of the product. For

more information, see FDA’s guidance: Content of Premarket Submissions for Device Software Functions, available

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-

device-software-functions

Contains Nonbinding Recommendations

This guidance applies to all types of devices within the meaning of section 201(h) of the Federal

Food, Drug, and Cosmetic Act (FD&C Act), including devices that meet the definition of a

biological product under section 351 of the Public Health Service Act, whether or not they

require a premarket submission. Therefore, the recommendations in this guidance also apply to

devices for which a premarket submission is not required (e.g., for 510(k)-exempt devices). This

guidance also applies to cyber devices, as defined in section 524B of the FD&C Act, which are a

subset of devices.

Generally, the recommendations in this guidance apply to the device constituent part of a

combination product

(such as drug-device and biologic-device combination products) when the

device constituent part presents cybersecurity considerations,

including but not limited to

devices that that have a device software function or that contain software (including firmware) or

programmable logic. For more information, contact the FDA review division that will have the

lead review for the combination product.

As IDE submissions have a different benefit-risk threshold and are not marketing authorizations,

specific recommendations for IDE submission documentation are provided in Appendix 3.

Additionally, Appendix 5 contains terminology used throughout the guidance.

III. Background

FDA recognizes that medical device cybersecurity is a shared responsibility among stakeholders

throughout the use environment of the medical device system, including healthcare facilities,

patients, healthcare providers, and manufacturers of medical devices. For the purposes of this

guidance, the term “medical device system” includes the device and systems—such as healthcare

facility networks, other devices, and software update servers—to which it is connected.

Events across the healthcare sector have stressed the importance of cybersecurity to patient

safety. The WannaCry

ransomware

affected hospital systems and medical devices across the

globe. Vulnerabilities identified in commonly used third-party components, like URGENT/11

and SweynTooth,

have led to potential safety concerns across a broad range of devices that are

21 CFR 3.2(e).

21 CFR 4.2.

This guidance has been prepared by CDRH and CBER, in consultation with the Center for Drug Evaluation and

Research (CDER) and the Office of Combination Products (OCP).

Additional information on the WannaCry Ransomware attack is available at https://h-isac.org/may-16-2017-

wannacry-update/

For the purposes of this guidance, we consider “ransomware” an ever-evolving form of malware designed to

encrypt files on a device, rendering any files and the systems that rely on them unusable. This definition is cited

from the Cybersecurity & Infrastructure Security Agency’s (CISA’s) webpage

https://www.cisa.gov/stopransomware/ransomware-101

For more information, see FDA’s Cybersecurity webpage, available at https://www.fda.gov/medical-

devices/digital-health-center-excellence/cybersecurity

The FDA Safety Communication on the SweynTooth vulnerabilities is available at

https://public4.pagefreezer.com/browse/FDA/08-02-2023T11:48/https:/www.fda.gov/medical-devices/safety-

communications/sweyntooth-cybersecurity-vulnerabilities-may-affect-certain-medical-devices-fda-safety-

communication

Contains Nonbinding Recommendations

used in various clinical specialties. In 2020, a ransomware attack on a German hospital

highlighted the potential impacts due to delayed patient care when a cybersecurity attack forced

patients to be diverted to another hospital.

FDA issued a final cybersecurity guidance addressing premarket expectations in 2014 “Content

of Premarket Submissions for Management of Cybersecurity in Medical Devices,” and the

complementary guidance “Postmarket Management of Cybersecurity in Medical Devices,”

hereafter referred to as the “Postmarket Cybersecurity Guidance,” in 2016. However, the rapidly

evolving landscape, an increased understanding of emerging threats, and the need for capable

deployment of mitigations throughout the total product lifecycle (TPLC) warrants an updated,

iterative approach to device cybersecurity. The changes since the 2014 guidance are intended to

further emphasize the importance of ensuring that devices are designed securely, are designed to

be capable of mitigating emerging cybersecurity risks throughout the TPLC, and to more clearly

outline FDA’s recommendations for premarket submission information to address cybersecurity

concerns.

One way these TPLC considerations for devices can be achieved is through the implementation

and adoption of a Secure Product Development Framework (SPDF).

An SPDF, as described in

this guidance, is a set of processes that reduce the number and severity of vulnerabilities in

products throughout the device lifecycle. Examples of such frameworks exist in many sectors

including the medical device sector.

Risk management for device manufacturers is the essential systematic practice of identifying,

analyzing, evaluating, controlling, and monitoring risk throughout the product lifecycle to ensure

that the devices they manufacture are safe and effective. The Quality System (QS) regulation in

21 CFR Part 820 explicitly addresses risk management activities in 21 CFR 820.30(g). Although

FDA is currently in the process of rulemaking

to revise the QS regulation, including 21 CFR

820.30(g), should FDA finalize the rule as proposed, the concept of risk management as

described in 21 CFR 820.30(g) would remain.

The recommendations contained in this guidance document are intended to supplement FDA’s

Postmarket Cybersecurity Guidance, “Cybersecurity for Networked Medical Devices Containing

Additional information on the German hospital ransomware attack is available at

https://www.wired.co.uk/article/ransomware-hospital-death-germany

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-

management-cybersecurity-medical-devices

See Appendix 5, Terminology.

On February 23, 2022, FDA issued a proposed rule to amend the device QS regulation, 21 CFR Part 820, to align

more closely with international consensus standards for devices (87 FR 10119; available at

https://www.federalregister.gov/documents/2022/02/23/2022-03227/medical-devices-quality-system-regulation-

amendments). Specifically, FDA proposed to withdraw the majority of the current requirements in Part 820 and

instead incorporate by reference the 2016 edition of the International Organization for Standardization (ISO) 13485,

Medical devices- Quality management systems- Requirements for regulatory purposes, in Part 820. As stated in that

proposed rule, the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of

the current Part 820, providing a similar level of assurance in a firm’s quality management system and ability to

consistently manufacture devices that are safe and effective and otherwise in compliance with the FD&C Act. FDA

intends to finalize this proposed rule expeditiously. When the final rule takes effect, FDA will also update the

references to provisions in 21 CFR Part 820 in this guidance to be consistent with that rule.

Contains Nonbinding Recommendations

Off-the-Shelf (OTS) Software,”

and “Content of Premarket Submissions for Device Software

Functions,”

hereafter referred to as the “Premarket Software Guidance.” This guidance replaces

the 2014 final guidance “Content of Premarket Submissions for Management of Cybersecurity in

Medical Devices.”

The recommendations in this guidance also generally align with or expand upon the

recommendations in the Pre-Market Considerations for Medical Device Cybersecurity section of

the International Medical Device Regulators Forum (IMDRF) final guidance “Principles and

Practices for Medical Device Cybersecurity,”

issued March 2020.

Additionally, section 3305 of the Consolidated Appropriations Act, 2023, enacted on December

29, 2022, added section 524B “Ensuring Cybersecurity of Medical Devices” to the FD&C Act.

Under section 524B(a) of the FD&C Act, a person who submits a 510(k), PMA, PDP, De Novo,

or HDE for a device that meets the definition of a cyber device, as defined under section 524B(c)

of the FD&C Act, is required to submit information to ensure that cyber devices meet the

cybersecurity requirements under section 524B(b) of the FD&C Act.

Section 524B(c) of the

FD&C Act defines “cyber device” as a device that “(1) includes software validated, installed, or

authorized by the sponsor as a device or in a device; (2) has the ability to connect to the internet;

and (3) contains any such technological characteristics validated, installed, or authorized by the

sponsor that could be vulnerable to cybersecurity threats.” The recommendations in this

guidance are intended to help manufacturers meet their obligations under section 524B of the

FD&C Act.

IV. General Principles

This section provides general principles for device cybersecurity relevant to device

manufacturers. The principles in this guidance document are important to the improvement of

device cybersecurity and, when followed, are expected to have a positive impact on the safety

and effectiveness of the device. The recommendations in this guidance cover all relevant

cybersecurity considerations that may affect device safety and effectiveness, including but not

limited to software, hardware, and firmware.

A. Cybersecurity is Part of Device Safety and the Quality

System Regulation

Device manufacturers must establish and follow quality systems to help ensure that their

products consistently meet applicable requirements and specifications. The quality systems

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-

networked-medical-devices-containing-shelf-ots-software

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-

premarket-submissions-software-contained-medical-devices

Available at http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-200318-pp-mdc-n60.pdf

In addition to the cybersecurity requirements set forth in section 524B(b) of the FD&C Act, section 524B(b)(4) of

the FD&C Act requires cyber device manufacturers to comply with any other such requirements FDA sets forth in

regulations “to demonstrate reasonable assurance that the device and related systems are cybersecure.”

Contains Nonbinding Recommendations

requirements are found in the QS regulation in 21 CFR Part 820. Depending on the device, QS

requirements may be relevant at the premarket stage, postmarket stage,

or both.

In the premarket context, in order to demonstrate a reasonable assurance of safety and

effectiveness for certain devices with cybersecurity risks, documentation outputs related to the

requirements of the QS regulation may be one source of documentation to include as part of the

premarket submission.

This guidance is intended to explain how such documentation that may

be relevant for QS regulation compliance can also be used to show how a sponsor or

manufacturer is addressing cybersecurity considerations relevant to a device. For example, 21

CFR 820.30(a) requires that for all classes of devices automated with software, a manufacturer

must establish and maintain procedures to control the design of the device in order to ensure that

specified design requirements are met (“design controls”). As part of design controls, a

manufacturer must “establish and maintain procedures for validating the device design,” which

“shall include software validation and risk analysis, where appropriate” (21 CFR 820.30(g)). As

part of the software validation and risk analysis required by 21 CFR 820.30(g), software device

manufacturers may need to establish cybersecurity risk management and validation processes,

where appropriate. See also FDA’s guidance titled “Content of Premarket Submissions for

Device Software Functions.”

Software validation and risk management are key elements of cybersecurity analyses and

demonstrating whether a device has a reasonable assurance of safety and effectiveness. FDA

requires manufacturers to implement development processes that account for and address

software risks throughout the design and development process as part of design controls, as

discussed in FDA’s regulations regarding design control, which may include cybersecurity

considerations.23 For example, these processes should address the identification of security

risks, the design requirements for how the risks will be controlled, and the evidence that the

controls function as designed and are effective in their environment of use for ensuring adequate

security.

1. A Secure Product Development Framework (SPDF) may be

one way to satisfy the QS regulation

Cybersecurity threats have the potential to exploit one or more vulnerabilities that could lead to

patient harm. The greater the number of vulnerabilities that exist and/or are identified over time

In the postmarket context, design controls may also be important to ensure medical device cybersecurity and

maintain medical device safety and effectiveness. FDA recommends that device manufacturers implement

comprehensive cybersecurity risk management programs and documentation consistent with the QS regulation,

including but not limited to complaint handling (21 CFR 820.198), quality audit (21 CFR 820.22), corrective and

preventive action (21 CFR 820.100), software validation and risk analysis (21 CFR 820.30(g)), and servicing (21

CFR 820.200).

The recommendations in this guidance are not intended to suggest that FDA will evaluate an applicant’s

compliance with the QS regulation as part of its premarket submission under section 510(k) of the FD&C Act in our

determination of a device’s substantial equivalence, as this is not a requirement for such decision under section

513(i) of the FD&C Act. This guidance is intended to explain how FDA evaluates the performance of device

cybersecurity and the cybersecurity outputs of activities that are part and parcel of QS regulation compliance, and

explain how the QS regulation can be leveraged to demonstrate these performance outputs.

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-

premarket-submissions-software-contained-medical-devices

See 21 CFR 820.30.

Contains Nonbinding Recommendations

in a system in which a device operates, the easier a threat can compromise the safety and

effectiveness of the medical device. An SPDF is a set of processes that help identify and reduce

the number and severity of vulnerabilities in products. An SPDF encompasses all aspects of a

product’s lifecycle, including design, development, release, support, and decommission.

Additionally, using SPDF processes during device design may prevent the need to re-engineer

the device when connectivity-based features are added after marketing and distribution, or when

vulnerabilities resulting in uncontrolled risks are discovered. An SPDF can be integrated with

existing processes for product and software development, risk management, and the quality

system at large.

Using an SPDF is one approach to help ensure that the QS regulation is met. Because of its

benefits in helping comply with the QS regulation and cybersecurity, FDA encourages

manufacturers to use an SPDF, but other approaches might also satisfy the QS regulation.

B. Designing for Security

When reviewing premarket submissions, FDA intends to assess device cybersecurity based on a

number of factors, including, but not limited to, the device’s ability to provide and implement the

security objectives below throughout the device architecture. The security objectives below

generally may apply broadly to devices within the scope of this guidance, including, but not

limited to, devices containing artificial intelligence and machine learning (AI/ML) and cloud-

based services.

Security Objectives:

• Authenticity, which includes integrity;

• Authorization;

• Availability;

• Confidentiality; and

• Secure and timely updatability and patchability.

Premarket submissions should include information that describes how the above security

objectives are addressed by and integrated into the device design. The extent to which security

requirements, architecture, supply chain, and implementation are needed to meet these objectives

will depend on but may not be limited to:

• The device’s intended use, indications for use, and reasonably foreseeable misuse;

• The presence and functionality of its electronic data interfaces;

• Its intended and actual environment of use;

• The risks presented by cybersecurity vulnerabilities;

• The exploitability of the vulnerabilities; and

• The risk of patient harm due to vulnerability exploitation.

Manufacturers may not be able to account for all potential environments of use, but should consider the range of

use environments and ensure the risks are identified and controlled for the worst-case environments of use (e.g.,

least secure expected network configuration(s)).

Contains Nonbinding Recommendations

SPDF processes aim to reduce the number and severity of vulnerabilities and thereby reduce the

exploitability of a medical device system and the associated risk of patient harm. Because

exploitation of known vulnerabilities or weak cybersecurity controls should be considered

reasonably foreseeable failure modes for medical device systems, these factors should be

addressed in the device design.

One of the key benefits of using an SPDF is that a medical

device system is more likely to be secure by design, such that the device is designed from the

outset to be secure within its system and/or network of use throughout the device lifecycle.

C. Transparency

A lack of cybersecurity information, such as information necessary to integrate the device into

the use environment, as well as information needed by users to maintain the medical device

system’s cybersecurity over the device lifecycle, has the potential to affect the safety and

effectiveness of a device. In order to address these concerns, it is important for device users to

have access to information pertaining to the device’s cybersecurity controls, potential risks to the

medical device system, and other relevant information. For example:

• A failure to disclose all of the communication interfaces or third-party software could fail

to convey potential sources of risks;

• Insufficient information pertaining to whether a device has known but not disclosed

cybersecurity vulnerabilities or risks may be relevant to determining whether a device’s

safety or effectiveness could be degraded; and/or

• Labeling that does not include sufficient information to explain how to securely configure

or update the device may limit the ability of end users to appropriately manage and

protect the medical device system.

This information and other relevant information are important in helping users understand a

medical device system’s resilience to cybersecurity threats, the threats that it may be exposed to,

and how those threats may be prevented or mitigated. Without it, cybersecurity risks could be

undisclosed, inappropriately identified, or inappropriately responded to, among other potential

impacts, which could lead to compromises in device safety and effectiveness.

FDA believes that the cybersecurity information discussed in this guidance is important for the

safe and effective use of devices and should be included in device labeling, as discussed below in

Section VI.

D. Submission Documentation

Device cybersecurity design and documentation are expected to scale with the cybersecurity risk

of that device. Manufacturers should take into account the larger system in which the device may

be used. For example, a cybersecurity risk assessment performed on a simple, non-connected

thermometer may conclude that the risks are limited, and therefore such a device needs only a

limited security architecture (i.e., addressing only device hardware and software) and few

security controls based on the technical characteristics and design of the device. However, if a

For more information on reasonably foreseeable misuse, see the IMDRF final guidance “Principles and Practices

for Medical Device Cybersecurity” available at

http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-200318-

pp-mdc-n60.pdf

Contains Nonbinding Recommendations

thermometer is used in a safety-critical control loop, or is connected to networks or other

devices, then the cybersecurity risks for the device are considered to be greater and more

substantial design controls should result. Submitters should consider including in premarket

submissions to FDA documentation generation from those design controls used during the

development of a device with cybersecurity risks as a way to demonstrate reasonable assurance

of safety and effectiveness. This guidance identifies the cybersecurity information FDA

recommends to help support a premarket submission for devices within the scope of this

guidance.

As cybersecurity is part of device safety and effectiveness, cybersecurity controls established

during premarket development should also take into consideration the intended and actual use

environment (see Section IV.B.). Cybersecurity risks evolve over time and as a result, the

effectiveness of cybersecurity controls may degrade as new risks, threats, and attack methods

emerge. In the 510(k) context, FDA evaluates the cybersecurity information submitted and the

protections the cybersecurity controls provide in demonstrating substantial equivalence (see

section 513(i) of the FD&C Act and 21 CFR 807.100(b)(2)(ii)(B)).

In addition, inadequate cybersecurity information in the device labeling may cause a device to be

misbranded under section 502(f) of the FD&C Act if its labeling does not bear adequate

directions for use or under section 502(j) of the FD&C Act because it is dangerous to health

when used in the manner recommended or suggested in the labeling, among other possible

violations. For cyber devices, failure to comply with any requirement under section 524B(b)(2)

(relating to ensuring device cybersecurity) is considered a prohibited act under section 301(q) of

the FD&C Act.

The cybersecurity information being recommended to be included in submissions as detailed in

this guidance is based on risks due to cybersecurity, not on any other criteria or level of

risk/concern established in a separate FDA guidance (e.g., the risk-based approach in the

Premarket Software Guidance to help determine a device’s Documentation Level). For example,

a device that is determined to have a greater software risk may only have a small cybersecurity

risk due to how the device is designed. Likewise, a device with a smaller software risk may have

a significant cybersecurity risk. Therefore, the recommendations in this guidance regarding

information to be submitted to the FDA are intended to address the cybersecurity risk, as

assessed by the cybersecurity risk assessment during development of a device, and are expected

to scale based on the cybersecurity risk. The premarket submission documentation

recommendations throughout this guidance apply to all premarket submissions and are intended

to be used to support FDA’s assessment of a device’s safety and effectiveness.

As previously discussed, section 524B of the FD&C Act requires the submission of certain documentation for

cyber devices.

For more information regarding the substantial equivalence review standard, please refer to FDA’s guidance, “The

510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)],” available at

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/510k-program-evaluating-substantial-

equivalence-premarket-notifications-510k

Contains Nonbinding Recommendations

For cyber devices, some of the information recommended in this guidance may help

manufacturers meet their obligations for what is required to be in premarket submissions under

section 524B.

V. Using an SPDF to Manage Cybersecurity Risks

The documentation recommended in this guidance is based on FDA’s experience evaluating the

safety and effectiveness of devices with cybersecurity vulnerabilities. However, sponsors may

use alternative approaches and provide different documentation so long as their approach and

documentation satisfy premarket submission requirements in applicable statutory provisions and

regulations. The increasingly interconnected nature of medical devices has demonstrated the

importance of addressing cybersecurity risks associated with device connectivity in device

design because of the effects on safety and effectiveness.

Cybersecurity risks to the medical

device or to the larger medical device system can be reasonably controlled through using an

SPDF.

The primary goal of using an SPDF is to manufacture and maintain safe and effective devices.

From a security standpoint, these are also trustworthy and resilient devices. These devices can

then be managed (e.g., installed, configured, updated, review of device logs) through the device

design and associated labeling by the device manufacturers and/or users (e.g., patients,

healthcare facilities). For healthcare facilities, these devices can also be managed within their

own cybersecurity risk management frameworks, such as the National Institute of Standards and

Technology (NIST) Framework for Improving Critical Infrastructure Cybersecurity, generally

referred to as the NIST Cybersecurity Framework or NIST CSF.

FDA recommends that manufacturers use device design processes such as those described in the

QS regulation to support secure product development and maintenance. To preserve flexibility

for manufacturers, manufacturers may use other existing frameworks that satisfy the QS

regulation and align with FDA’s recommendations for using an SPDF. Possible frameworks to

consider include, but are not limited to the medical device-specific framework that can be found

in the Medical Device and Health IT Joint Security Plan (JSP)

and IEC 81001-5-1.

Frameworks from other sectors may also comply with the QS regulations, like the framework

provided in ANSI/ISA 62443-4-1 Security for industrial automation and control systems Part 4-

1: Product security development life-cycle requirements.

The following subsections provide recommendations for using SPDF processes that FDA

believes provide important considerations for the development of devices that are safe and

effective, how these processes can complement the QS regulation, and the documentation FDA

recommends manufacturers provide for review as part of premarket submissions. The

Addressing cybersecurity risks is in addition to addressing other risks, including software, biocompatibility,

sterilization, and electromagnetic compatibility, among others.

For more information, please see the NIST Cybersecurity Framework available at

https://www.nist.gov/cyberframework

Medical Device and Health IT Joint Security Plan (JSP) is available at https://healthsectorcouncil.org/the-joint-

security-plan/

ANSI/ISA-62443-4-1 Security for industrial automation and control systems Part 4-1: Product security

development life-cycle requirements outlines a secure product development lifecycle similar to that of the JSP.

Contains Nonbinding Recommendations

information in these sections do not represent a complete SPDF. For more information on

SPDFs, see earlier in Section V. In addition, FDA does not recommend that manufacturers

discontinue existing, effective processes.

A. Security Risk Management

To fully account for cybersecurity risks in medical device systems, the safety and security risks

of each device should be assessed within the context of the larger system in which the device

operates. In the context of cybersecurity, security risk management processes are critical

because, given the evolving nature of cybersecurity threats and risks, no device is, or can be,

completely secure. Security risk management should be an integrated part of a manufacturer’s

entire quality system, addressed throughout the TPLC.

The quality system processes entail the

technical, personnel, and management practices, among others, that manufacturers use to manage

potential risks to their devices and ensure that their devices are, and once on the market, remain,

safe and effective, which includes security.

Performing security risk management is distinct from performing safety risk management as

described in ISO 14971. The distinction in the performance of these processes is due to the fact

that in the security context versus the safety context, the scope of possible harm and the risk

assessment factors may be different. Also, while safety risk management focuses on physical

injury, damage to property or the environment, or delay and/or denial of care due to device or

system unavailability, security risk management may include risks that can result in indirect or

direct patient harm. Additionally, risks that are outside of FDA’s assessment of safety and

effectiveness, such as those related to business or reputational risks, may also exist.

The scope and objective of a security risk management process, in conjunction with other SPDF

processes (e.g., security testing), is to expose how threats, through vulnerabilities, can manifest

patient harm and other potential risks. These processes should also ensure that risk control

measures for one type of risk assessment do not inadvertently introduce new risks in the other.

For example, AAMI TIR57 details how the security and safety risk management processes

should interface to ensure all risks are adequately assessed.

FDA recommends that security risk

management processes, as detailed in the QS regulation,

be established or incorporated into

those that already exist, and should address the manufacturer’s design, manufacturing, and

distribution processes, as well as updates across the TPLC. The processes in the QS regulation

which may be relevant in this context include, but are not limited to design controls (21 CFR

820.30), validation of production processes (21 CFR 820.70), and corrective and preventive

actions (21 CFR 820.100) to ensure both safety and security risks are adequately addressed. For

completeness in performing risk analyses under 21 CFR 820.30(g), FDA recommends that

device manufacturers conduct both a safety risk assessment and a separate, accompanying

security risk assessment to ensure a more comprehensive identification and management of

patient safety risks.

The TPLC processes include design and development, manufacturing, postmarket monitoring, delivering device

software and firmware updates, and servicing, among others.

AAMI TIR57 Principles for medical device security—Risk management describes the security risk management

process and how the security risk management process should have links into the safety risk management process

and vice versa.

21 CFR 820.

Contains Nonbinding Recommendations

A device should be designed to eliminate or mitigate known vulnerabilities. For marketed

devices, if comprehensive design mitigations are not possible, compensating controls should be

considered. For all devices, when any known vulnerabilities are only partially mitigated or

unmitigated by the device design, they should be assessed as reasonably foreseeable risks in the

risk assessment and be assessed for additional control measures or risk transfer

to the

user/operator, or, if necessary, the patient. Risk transfer, if appropriate, should only occur when

all relevant risk information is known, assessed, and appropriately communicated to users and

includes risks inherited from the supply chain as well as how risk transfer will be handled when

the device or manufacturer-controlled assets of the medical device system reaches end of support

and end of life and whether or how the user is able to take on that role (e.g., if the user may be a

patient).

To document the security risk management activities for a medical device system, FDA

recommends that manufacturers generate a security risk management plan and report such as that

described in AAMI TIR57.

Manufacturers should include their security risk management

reports—including the outputs of their security risk management processes—in their premarket

submissions to help demonstrate the safety and effectiveness of the device. A security risk

management report, such as that described in that in AAMI TIR57, should be sufficient to

support the security risk management process aspect of demonstrating a reasonable assurance of

safety and effectiveness. Such report should include the documentation elements for the system

threat modeling, cybersecurity risk assessment, Software Bill of Materials (SBOM), component

support information, vulnerability assessments, and unresolved anomaly assessment(s) described

in the sections below.

In the subsections below, we discuss FDA’s recommendations regarding

the scope and/or content of specific security risk management documentation elements.

In addition to containing the documentation elements listed above, the security risk management

report should:

• Summarize the risk evaluation methods and processes,

• Detail the residual risk conclusion from the security risk assessment,

• Detail the risk mitigation activities undertaken as part of a manufacturer’s risk

management processes, and

• Provide traceability between the threat model, cybersecurity risk assessment, SBOM, and

testing documentation as discussed later in this guidance as well as other relevant

cybersecurity risk management documentation.

For the purposes of this guidance, we consider “risk transfer” to include actions taken to manage risk that shifts

some or all of the risk to another user, asset, system, network, or geographic area. This definition is adapted from the

DHS Risk Lexicon available at https://www.cisa.gov/resources-tools/resources/dhs-risk-lexicon

Details on the content for security risk management plans and reports beyond those specifically identified can be

found in AAMI TIR57 Principles for medical device security—Risk management.

While security architecture is likely captured as a component of the security risk management process, it is

discussed separately for the purposes of this guidance due to the level of detail recommended to be provided by

manufacturers in order to facilitate FDA review of the safety and effectiveness of the device.

Contains Nonbinding Recommendations

1. Threat Modeling

Threat modeling includes a process for identifying security objectives, risks, and vulnerabilities

across the medical device system, and then defining countermeasures to prevent, mitigate,

monitor, or respond to the effects of threats to the medical device system throughout its lifecycle.

It is foundational for optimizing system, product, network, application, and connection security

when applied appropriately and comprehensively.

With respect to security risk management, and in order to identify appropriate security risks and

controls for the medical device system, FDA recommends that threat modeling be performed to

inform and support the risk analysis activities. As part of the risk assessment, FDA recommends

threat modeling be performed throughout the design process and be inclusive of all medical

device system elements.

The threat model should:

• Identify medical device system risks and mitigations as well as inform the pre- and

post-mitigation risks considered as part of the cybersecurity risk assessment;

• State any assumptions about the medical device system or environment of use (e.g.,

hospital networks are inherently hostile, therefore manufacturers are recommended to

assume that an adversary controls the network with the ability to alter, drop, and replay

packets); and

• Capture cybersecurity risks introduced through the supply chain, manufacturing,

deployment, interoperation with other devices, maintenance/update activities, and

decommission activities that might otherwise be overlooked in a traditional safety risk

assessment process.

FDA recommends that premarket submissions include threat modeling documentation to

demonstrate how the medical device system has been analyzed to identify potential security risks

that could impact safety and effectiveness. There are a number of methodologies and/or

combinations of methods for threat modeling that manufacturers may choose to use.

Rationale

for the methodology(ies) selected should be provided with the threat modeling documentation.

Additional recommendations on how threat modeling documentation should be submitted to

FDA are discussed in Section V.B. below.

Threat modeling activities can be performed and/or reviewed during design reviews. FDA

recommends that threat modeling documentation include sufficient information on threat

modeling activities performed by the manufacturer to assess and review the security features

built into the device such that they holistically evaluate the device and the system in which the

device operates, for the safety and effectiveness of the device.

The MDIC/MITRE Playbook for Threat Modeling Medical Devices is an educational resource that discusses the

threat modeling process, different threat modeling techniques, and provides fictional medical device examples. The

playbook is available at https://www.mitre.org/news-insights/publication/playbook-threat-modeling-medical-devices

Contains Nonbinding Recommendations

2. Cybersecurity Risk Assessment

As a part of security risk management, security risks and controls should be assessed for residual

risks as part of a cybersecurity risk assessment. Effective security risk assessments address the

fact that cybersecurity-related failures can occur either intentionally or unintentionally.

Accordingly, cybersecurity risks are difficult to predict, meaning that it is not possible to assess

and quantify the likelihood of an incident occurring based on historical data or modeling (also

known as a “probabilistic manner”). This non-probabilistic approach is not the fundamental

approach performed in safety risk management under ISO 14971 and further underscores why

safety and security risk management are distinct but connected processes. Instead, security risk

assessment processes focus on exploitability, or the ability to exploit vulnerabilities present

within a device and/or system. FDA recommends that manufacturers assess identified risks

according to the level of risk posed from the device and the system in which it operates.

Additional discussion on exploitability assessments for the security risk assessment can be found

in the FDA’s Postmarket Cybersecurity Guidance.

The premarket assessment of exploitability of a cybersecurity risk may be different from the

exploitability assessment of a vulnerability discovered postmarket. For example, some of the

exploitability factors discussed in the Postmarket Cybersecurity Guidance (e.g., Exploit Code

Maturity, Remediation Level, Report Confidence)

may not be applicable to unreleased

software. In these instances, a premarket exploitability assessment could either assume a worst-

case assessment and implement appropriate controls, or provide a justification for a reasonable

exploitability assessment of the risk throughout the TPLC and how the risk is controlled.

Acceptance criteria for cybersecurity risks should carefully consider the TPLC of the medical

device system, as it might be more difficult to mitigate cybersecurity issues once the device is

marketed. As discussed above in Sections IV.B. and V.A., known vulnerabilities should be

assessed as reasonably foreseeable risks. The cybersecurity risk assessment for vulnerabilities

identified during cybersecurity testing should also consider the TPLC of the device as the

exploitability of the vulnerability is likely to increase over the device lifecycle. If a vulnerability

scan or penetration tester, for example, was able to exploit a vulnerability, the ability of a threat

actor to exploit that vulnerability is likely to increase over the device lifecycle. Furthermore,

vulnerabilities identified in Cybersecurity and Infrastructure Security Agency (CISA) Known

Exploited Vulnerabilities Catalog

should be designed out of the device, as they are already

being exploited and expose the medical device system and users to the risk.

FDA recommends that the cybersecurity risk assessment provided in premarket submissions

should capture the risks and controls identified from the threat model. The methods used for

scoring the risk pre- and post-mitigation and the associated acceptance criteria as well as the

method for transferring security risks into the safety risk assessment process should also be

provided as part of the premarket submission.

These factors of exploitability are from the Common Vulnerability Scoring System (CVSS) Version 3.0 as

identified in the Postmarket Cybersecurity Guidance (available at

https://www.fda.gov/regulatory-

information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices). Additional

information on CVSS is available at https://www.first.org/cvss/

Available at https://www.cisa.gov/known-exploited-vulnerabilities-catalog

Contains Nonbinding Recommendations

3. Interoperability Considerations

Interoperability is an important consideration when assessing the cybersecurity of the end-to-end

medical device system. As identified in the FDA guidance “Design Considerations and

Premarket Submission Recommendations for Interoperable Medical Devices,”

hereafter

referred to as the “Interoperability Guidance,” interoperable medical devices have the ability to

exchange and use information through an electronic interface with another medical or

nonmedical product, system, or device.

As part of a medical device system, a device may have cybersecurity considerations from

interoperable functionality, including but not limited to interfaces with:

• Other medical devices and accessories;

• ‘Other functions’ as identified in the FDA’s guidance “Multiple Function Device

Products: Policy and Considerations;”

• Interoperability with healthcare infrastructure (e.g., network, Electronic Medical Records,

medical imaging systems); and

• General purpose computing platforms.

While cybersecurity controls may increase the complexity of interfaces to allow for

interoperability, when properly implemented, the cybersecurity controls can help assure that

these capabilities remain safe and effective. Cybersecurity controls should be used as a means to

allow for the safe and effective exchange and use of information. Additionally, cybersecurity

controls should not be intended to prohibit a user from accessing their device data.

When common technology and communication protocols are used to enable interoperability

(e.g., Bluetooth, Bluetooth Low Energy, network protocols), device manufacturers should assess

whether added security controls beneath such communication are needed to ensure the safety and

effectiveness of the device (e.g., added security controls beneath Bluetooth Low Energy to

protect against risks if vulnerabilities in the Bluetooth Low Energy protocol or supporting

technology are discovered).

In addition to the recommendations in the Interoperability Guidance, manufacturers should

consider the appropriate cybersecurity risks and controls associated with the interoperability

capabilities and document these considerations as recommended throughout this guidance.

4. Third-Party Software Components

As discussed in the FDA guidances “Off-The-Shelf (OTS) Software Use in Medical Devices”

and “Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software,”

medical devices commonly include third-party software components,

including off-the-shelf

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-

and-pre-market-submission-recommendations-interoperable-medical-devices

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/multiple-function-

device-products-policy-and-considerations

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-

medical-devices

The use of “component” in this guidance is consistent with the definition in 21 CFR 820.3.

Contains Nonbinding Recommendations

and open source software. When these components are incorporated, security risks of the

software components should become factors of the overall medical device system risk

management processes and documentation.

As part of demonstrating compliance with design controls under 21 CFR 820.30(g), and to

support supply chain risk management processes, all software, including those developed by the

device manufacturer (“proprietary software”) or obtained from third parties, should be assessed

for cybersecurity risk. Device manufacturers should document all software components of a

device and address or otherwise mitigate risks associated with these software components.

In addition, under 21 CFR 820.50, a manufacturer must put in place processes and controls to

ensure that its suppliers conform to the manufacturer’s requirements. Such information is

documented in the Design History File, required by 21 CFR 820.30(j), and Device Master

Record, required by 21 CFR 820.181. This documentation demonstrates the device’s overall

compliance with the QS regulation, as well as that the third-party components meet

specifications established for the device. Security risk assessments that include analyses and

considerations of cybersecurity risks that may exist in or be introduced by third-party software

and the software supply chain may help demonstrate that manufacturers have adequately ensured

such compliance and documented such history.

Software is updated over time to provide additional features, address security concerns, and

otherwise be maintained. These changes may introduce new considerations or risks that must be

accounted for as part of risk management. As a result, device manufacturers should establish and

maintain custodial control of device source code (the original “copy” of the software) throughout

the lifecycle of a device as part of configuration management.

This may be accomplished

through different methods, such as source code escrow or source code backups, among others.

Manufacturers may not have control of source code due to licensing restrictions, terms of

supplier agreements, or other challenges. While source code is not required to be provided in

premarket submissions, manufacturers should include plans for how third-party software

components could be updated or replaced if support ends or other software issues arise in

premarket submissions. The device manufacturer should also provide users with whatever

information they may need in the device labeling to allow them to manage risks associated with

the software components, including known vulnerabilities, configuration specifications, and

other relevant security and risk management considerations.

One tool to help manage supply chain risk as well as clearly identify and track the software

incorporated into a device is an SBOM, as described below.

While some suppliers may not grant access to source code, manufacturers may consider adding to their purchasing

controls acquisition of the source code should the purchased software reach end of support or end of life from the

supplier earlier than the intended end of support or end of life of the medical device.

Source code escrow involves depositing a copy of a relevant piece of software's source code (and related technical

components and documentation) with an independent third party (“escrow agent”). Source code backup involves

storing (and updating as needed) a separate copy of the source code.

Contains Nonbinding Recommendations

(a) Software Bill of Materials (SBOM)

An SBOM can aid in the management of cybersecurity risks that exist throughout the software

stack. A robust SBOM includes both the device manufacturer-developed components and third-

party components, including purchased/licensed software and open-source software, and the

upstream software dependencies that are required/depended upon by proprietary,

purchased/licensed, and open-source software.

An SBOM helps facilitate risk management processes by providing a mechanism to identify

devices and the systems in which they operate that might be affected by vulnerabilities in the

software components, both during development when software is being chosen as a component

and after it has been placed into the market throughout all other phases of a product’s life.

Because vulnerability management is a critical part of a device’s security risk management

processes, an SBOM or an equivalent capability should be maintained as part of the device’s

configuration management, be regularly updated to reflect any changes to the software in

marketed devices, and should support documentation, such as the types detailed in 21 CFR

820.30(j) (Design History File) and 820.181 (Device Master Record).

To assist FDA’s assessment of the device risks and associated impacts on safety and

effectiveness related to cybersecurity, FDA recommends that premarket submissions include

SBOM documentation as outlined below. For cyber devices, an SBOM is required (see section

524B(b)(3) of the FD&C Act). SBOMs can also be an important tool for transparency with users

of potential risks as part of labeling as addressed later in Section VI.

(b) Documentation Supporting Software Bill of Materials

FDA’s guidance documents “Off-The-Shelf (OTS) Software Use in Medical Devices”

and

“Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software”

describe information that should be provided in premarket submissions for software components

for which a manufacturer cannot claim complete control of the software lifecycle. In addition to

the information recommended in those guidances, manufacturers should provide machine-

readable SBOMs consistent with the minimum elements (also referred to as “baseline attributes”)

identified in the October 2021 National Telecommunications and Information Administration

(NTIA) Multistakeholder Process on Software Component Transparency document “Framing

Software Component Transparency: Establishing a Common Software Bill of Materials

(SBOM).”

In addition to the minimum elements identified by NTIA, for each software component

contained within the SBOM, manufacturers should include in the premarket submission:

For additional information, see the Department of Commerce National Telecommunications and Information

Administration’s multi-stakeholder process for software transparency, available at

https://www.ntia.doc.gov/SoftwareTransparency

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-

medical-devices

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-

networked-medical-devices-containing-shelf-ots-software

Available at https://ntia.gov/sites/default/files/publications/ntia_sbom_framing_2nd_edition_20211021_0.pdf

CISA will be providing future updates to this document.

Contains Nonbinding Recommendations

• The software level of support provided through monitoring and maintenance from the

software component manufacturer (e.g., the software is actively maintained, no longer

maintained, abandoned); and

• The software component’s end-of-support date.

When provided, manufacturers may choose to provide these additional elements as part of the

SBOM, or they may provide it separately, such as in an addendum. Industry-accepted formats of

SBOMs are encouraged.

If a manufacturer is unable to provide the SBOM information to FDA, the manufacturer should

provide a justification for why the information cannot be included in the premarket submission.

As part of the premarket submission, manufacturers should also identify all known

vulnerabilities associated with the device and the software components, including those

identified in CISA’s Known Exploited Vulnerabilities Catalog.

For each known vulnerability,

manufacturers should describe how the vulnerabilities were discovered to demonstrate whether

the assessment methods were sufficiently robust. For components with known vulnerabilities,

device manufacturers should provide in premarket submissions:

• A safety and security risk assessment of each known vulnerability (including device and

system impacts); and

• Details of applicable safety and security risk controls to address the vulnerability. If risk

controls include compensating controls, those should be described in an appropriate level

of detail.

For additional information and discussion regarding proprietary and third-party components, see

Section V.B.2., Security Architecture Views, below.

5. Security Assessment of Unresolved Anomalies

FDA’s Premarket Software Guidance, recommends that device manufacturers provide a list of

software anomalies that exist in a product at the time of submission. For each of these anomalies,

FDA recommends that device manufacturers conduct an evaluation of the anomaly’s impact on

the device’s safety and effectiveness, and consult the Premarket Software Guidance to assess the

associated documentation recommended for inclusion in such device’s premarket submission.

Some anomalies discovered during development or testing may have security implications and

may also be considered vulnerabilities. As a part of ensuring a complete security risk assessment

under 21 CFR Part 820.30(g), the assessment for impacts to safety and effectiveness may include

an assessment for the potential security impacts of anomalies. The assessment should also

include consideration of any present Common Weakness Enumeration (CWE) categories.

Available at https://www.cisa.gov/known-exploited-vulnerabilities-catalog

Examples of SW91 defect classification mapped to CWE can be found in Annex D of AAMI SW91 Classification

of Defects in Health Software. Additional information on CWE categories can be found at https://cwe.mitre.org/

Contains Nonbinding Recommendations

For example, a clinical user may inadvertently reveal the presence of a previously unknown

software anomaly during normal use, where the impact of the anomaly might occur sporadically

and be assessed to be acceptable from a software risk perspective. Conversely, a threat might

seek out these types of anomalies, and identify means to exploit them in order to manifest the

anomaly’s impact continuously, which could significantly impact the acceptability of the risk

when compared to an anomaly assessment that didn’t include security considerations.

The criteria and rationales for addressing the resulting anomalies with security impacts should be

provided as part of documentation in the premarket submission.

6. TPLC Security Risk Management

Cybersecurity risks may continue to be identified throughout the device’s TPLC. Manufacturers

should ensure they have appropriate resources to identify, assess, and mitigate cybersecurity

vulnerabilities as they are identified throughout the supported device lifecycle.

As part of using an SPDF, manufacturers should update their security risk management

documentation as new information becomes available, such as when new threats, vulnerabilities,

assets, or adverse impacts are discovered during development and after the device is released.

When maintained throughout the device lifecycle, this documentation (e.g., threat modeling) can

be used to quickly identify vulnerability impacts once a device is released and, when appropriate,

to support timely corrective and preventive action activities described in 21 CFR 820.100.

Over the service life of a device, FDA recommends that the risk management documentation

account for any differences in the risk management for fielded devices (e.g., marketed devices or

devices no longer marketed but still in use). For example, if an update is not applied

automatically for all fielded devices, then there will likely be different risk profiles for differing

software configurations of the device. FDA recommends that vulnerabilities be assessed for any

differing impacts for all fielded versions to ensure patient risks are being accurately assessed.

Additional information as to whether a new premarket submission (e.g., PMA, PMA supplement,

or 510(k)) or 21 CFR Part 806 reporting is needed based on postmarket vulnerabilities and

general postmarket cybersecurity risk management is discussed in the Postmarket Cybersecurity

Guidance.

To demonstrate the effectiveness of a manufacturer’s processes, FDA recommends that a

manufacturer track and record the measures and metrics below,

and provide them in premarket

submissions and PMA annual reports (21 CFR 814.84), when available.

Selecting appropriate

measures and metrics for the processes that define an SPDF is important to ensure that device

design appropriately addresses cybersecurity in compliance with the QS regulation. At a

minimum, FDA recommends tracking the following measures and metrics, or those that provide

equivalent information:

The measures and metrics provided are examples; alternative or additional measures and metrics may also be

considered and reported.

If a manufacturer has not marketed prior versions or the premarket submission does not pertain to a marketed

product (e.g., PMA supplement), FDA acknowledges that these measures and metrics might not be available, but

recommends that manufacturers include these as part of their risk management plan and SPDF processes.

Contains Nonbinding Recommendations

• Percentage of identified vulnerabilities that are updated or patched (defect density);

• Duration from vulnerability identification to when it is updated or patched; and

• Duration from when an update or patch is available to complete implementation in

devices deployed in the field, to the extent known.

Averages of the above measures should be provided if multiple vulnerabilities are identified and

addressed. These averages may be provided over multiple time frames based on volume or in

response to process or procedure changes to increase efficiencies of these measures over time.

B. Security Architecture

Manufacturers are responsible for identifying cybersecurity risks in their devices and the systems

in which they expect those devices to operate, and implementing the appropriate controls to

mitigate those risks. These risks may include those introduced by device reliance on hospital

networks, cloud infrastructure, or “other functions” (as defined in FDA’s guidance Multiple

Function Device Products: Policy and Considerations), for example. A security architecture, like

a system architecture, defines the system and all end-to-end connections into and/or out of the

system. A security architecture definition process

includes both high-level definitions of the

devices and/or systems that interact, and detailed information on the implementations for how

those interactions occur and are secured. It contains information that demonstrates that the risks

considered during the risk management process are adequately controlled, which, in turn,

supports the demonstration of the safety and effectiveness of the medical device system.

Under 21 CFR 820.30(b), a manufacturer must establish and maintain plans that describe or

reference the design and development activities and define responsibility for implementation.

Such plans must be reviewed, updated, and approved as design and development evolves (21

CFR 820.30(b)). Under 21 CFR 820.30(c), a manufacturer must establish and maintain

procedures to ensure that the design requirements relating to a device are appropriate and address

the intended use of the device, including the needs of the user and patient. Under 21 CFR

820.30(d), a manufacturer must establish and maintain procedures for defining and documenting

design output in terms that allow an adequate evaluation of conformance to design input

requirements. 21 CFR 820.30(d) also states that design output procedures shall contain or make

reference to acceptance criteria and shall ensure that those design outputs that are essential for

the proper functioning of the device are identified.

FDA recommends that these plans and procedures include design processes, design

requirements, and acceptance criteria for the security architecture of the device such that they

holistically address the cybersecurity considerations for the device and the system in which the

device operates. FDA recommends that all medical devices provide and enforce the security

objectives in Section IV., above, but recognizes that implementations to address the security

objectives may vary.

NIST 800-160 vol. 1 rev. 1, Engineering Trustworthy Secure Systems states that security architecture

definition process generates a set of representative security views of the system architecture to inform the

selection of an appropriate security architecture. The process also ascertains vulnerability and susceptibility to

disruptions, hazards, and threats. NIST 800-160 vol. 1 rev. 1 is available at

https://csrc.nist.gov/pubs/sp/800/160/v1/r1/final

Contains Nonbinding Recommendations

FDA recommends that premarket submissions include documentation on the security

architecture. The objective in providing security architecture information in premarket

submissions is to provide to the FDA the security context and trust-boundaries of the medical

device system in terms of the interfaces, interconnections, and interactions that the medical

device system has with external entities. The details of these elements enable the identification of

the parts of the medical device system in or through which incidents might occur. These details

help to provide a sufficient understanding of the system such that FDA can evaluate adequacy of

the architecture itself as it relates to safety and effectiveness.

Manufacturers should analyze the entire system to understand the full environment and context

in which the device is expected to operate. The security architecture should include a

consideration of system-level risks, including but not limited to risks related to the supply chain

(e.g., to ensure the device remains free of malware, or vulnerabilities inherited from upstream

dependencies such as third-party software, among others), design, production, and deployment

(i.e., into a connected/networked environment).

FDA recommends that this architecture information take the form of “views,” and that these

views be provided during premarket submissions to demonstrate safety and effectiveness.

If the

documentation identified in this section already exists in other risk management documentation,

FDA does not expect manufacturers to separate out this information into new document(s); such

documentation can be provided and the submission can reference the relevant sections.

Below, FDA outlines the recommended security controls and ways to document the resultant

security architecture in premarket submissions through specific Security Architecture Views.

1. Implementation of Security Controls

FDA considers the way in which a device addresses cybersecurity risks and the way in which the

device responds when exposed to cybersecurity threats as functions of the device design.

Effective cybersecurity relies upon security being “built in” to a device, and not “bolted on” after

the device is designed. FDA recommends that device manufacturers’ design processes include

design inputs for cybersecurity controls.

Under 21 CFR 820.30(c), a manufacturer must

establish and maintain procedures to ensure that the design requirements relating to a device are

appropriate and address the intended use of the device, including the needs of the user and

patient. Under 21 CFR 820.30(d), a manufacturer must establish and maintain procedures for

defining and documenting design output in terms that allow an adequate evaluation of

conformance to design input requirements. These output procedures shall contain or make

reference to acceptance criteria and shall ensure that those design outputs that are essential for

the proper functioning of the device are identified.

Views are discussed in more detail in the following subsections and Appendix 2.

There are useful frameworks to use in the generation of these design inputs including the OWASP Security by

design principles, AAMI/ISA-62443-4-1, as well as medical device specific frameworks including the Hippocratic

Oath for Connected Medical Devices, Building Code for Medical Device Software Security, and IEC 81001-5-1.

For a specific implementation of the OWASP Security by design principles, see the Medical Device and Health IT

Joint Security Plan (JSP) available at https://healthsectorcouncil.org/the-joint-security-plan/

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FDA recommends that these procedures include design requirements and acceptance criteria for

the security features built into the device such that they holistically address the cybersecurity

considerations for the device and the system in which the device operates.

Security controls allow manufacturers to achieve the security objectives outlined in Section IV.

and are an integral part of an SPDF. FDA recommends that an adequate set of security controls

should include, but not necessarily be limited to, controls from the following categories:

• Authentication;

• Authorization;

• Cryptography;

• Code, Data, and Execution Integrity;

• Confidentiality;

• Event Detection and Logging;

• Resiliency and Recovery; and

• Updatability and Patchability.

For each of the security control categories above, specific control recommendations and

implementation guidance to avoid common pitfalls are detailed in Appendix 1.

Implementation of security controls should be applied across the system architecture using risk-

based determinations associated with the subject connections and devices. Without adequate

security controls across the medical device system—which include management, technical, and

operational controls—there is no reasonable assurance of safety and effectiveness. Additionally,

deficiencies in the design of selected security controls or the implementation of those controls

can have dramatic impacts on a device’s ability to demonstrate or maintain its safety and

effectiveness.

FDA recommends the requirements and acceptance criteria for each of the above categories be

provided in premarket submissions to demonstrate safety and effectiveness. Manufacturers

should submit documentation in their premarket submissions demonstrating that the security

controls for the categories above, and further detailed in the recommendations in Appendix 1,

have (1) been implemented, and (2) been tested in order to validate that they were effectively

implemented. For more information on cybersecurity testing, see Section V.C., below.

Manufacturers may include the demonstration of security controls that are comparable or in

addition to those described in Appendix 1 in their premarket submissions. If using alternate

controls that are not described in this document, manufacturers should provide documentation

and tracing of specific design features and security controls to the associated risks in order to

demonstrate that they provide appropriate levels of safety and effectiveness. As cybersecurity

design controls are established early in the development phase, FDA recommends that device

manufacturers utilize the FDA Q-submission process to discuss design considerations for

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cybersecurity risk management throughout the device lifecycle with the agency.

Additional

information on premarket documentation recommendations for design controls are discussed in

the Security Architecture Views section below.

2. Security Architecture Views

In addition to the design control requirements,

21 CFR 820.100 requires that manufacturers

establish and maintain procedures for implementing corrective and preventive action, which

must include, among other things, requirements for analyzing quality data to identify existing

and potential causes of quality problems. FDA recommends that manufacturers develop and

maintain security architecture view documentation as a part of the process for the design,

development, and maintenance of the medical device system. If corrective and preventive actions

are identified, these views can be used to help identify impacted functionality and solutions that

address the risks.

FDA recommends that premarket submissions include the architecture views described in this

section. These architecture views can contribute to the demonstration of safety and effectiveness

in premarket submissions by illustrating how the controls to address cybersecurity risks have

been applied to the medical device system.

The security architecture may be expressed at different levels of abstraction and with different

scopes or views.

The number and extent of the architecture views provided in the submission

depends on the attack surface(s) identified through threat modeling and risk assessments for the

medical device system. These views can therefore be an effective way to provide threat modeling

information to FDA and will naturally scale the documentation provided with the cybersecurity

risk of the device.

FDA recommends providing, at minimum, the following types of views in premarket

submissions:

• Global System View;

• Multi-Patient Harm View;

• Updateability/Patchability View; and

• Security Use Case View(s).

Documenting these views in premarket submissions should include both diagrams and

explanatory text. These diagrams and explanatory text should contain sufficient details to permit

an understanding of how the assets within the medical device system function holistically within

the associated implementation details. For the security architecture views, manufacturers should

For more information, see FDA’s guidance “Request for Feedback on Medical Device Submissions: The Q-

Submission Program,” available at

https://www.fda.gov/regulatory-information/search-fda-guidance-

documents/requests-feedback-and-meetings-medical-device-submissions-q-submission-program

See 21 CFR 820.30.

Architecture view is defined by NIST 800-160 vol. 1 rev. 1 as “A work product expressing the architecture of a

system from the perspective of specific system concerns.” NIST 800-160 vol. 1 rev. 1 is available at

https://csrc.nist.gov/pubs/sp/800/160/v1/r1/final

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follow the recommendations outlined in Appendix 2 when determining the level of detail to

include in premarket submissions.

These security architecture views should:

• Identify security-relevant medical device system elements and their interfaces;

• Define security context, domains, boundaries, critical user roles, and external interfaces

of the medical device system;

• Align the architecture with (a) the medical device system security objectives and

requirements, (b) security design characteristics in order to address the identified threats;

and

• Establish traceability of architecture elements to user and medical device system security

requirements. Such traceability should exist throughout the cybersecurity risk

management documentation.

If a particular view sufficiently captures the risks of another view identified above, we do not

expect manufacturers to duplicate documentation. Similarly, if threat modeling documentation

sufficiently captures the view, we do not expect manufacturers to duplicate documentation.

Additionally, if one of the views listed above is not appropriate, manufacturers should instead

provide an explanation for why the view is not included in the premarket submission.

The extent of these security views in a premarket submission is expected to scale based on the

architecture and potential cybersecurity risk posed to the device. For example, medical device

systems with network and/or cloud access would be expected to have more Security Use Case

Views than a medical device system that has only a USB interface.

(a) Global System View

A global system view should describe the overall medical device system, including the device

itself and all internal and external connections. For interconnected and networked devices, this

view should identify all interconnected elements, including any software update infrastructure(s),

healthcare facility network impacts, intermediary connections or devices, cloud connections,

patient home network impact.

Depending on the complexity of the medical device system, it may not be feasible to include all

data flow specifics in a singular global system view. Additional views can be provided that detail

the communication specifics as recommended in Appendix 2 and do not need to be duplicated if

captured in one of the other types of views detailed below.

(b) Multi-Patient Harm View

When devices are capable of connecting (wired or wirelessly) to another medical or non-medical

product, to a network, or to the Internet, there is the possibility that multiple devices can be

compromised simultaneously. Because of that connectivity, if a device is compromised, or if a

non-device function (i.e., any function that does not fall within section 201(h) of the FD&C Act)

that could impact the device function is compromised, the device may introduce a safety risk to

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patients through security risk. This may change the device’s functionality. For example, a non-

device function could be hacked to perform a device function and ultimately harm patients.

Depending on the device risk and use environment, a multiple-device compromise may have

severe impacts for multiple patients, either through impact to the device itself and/or to

healthcare facility operations (e.g., multiparameter bedside monitors all restarting at once,

leaving all monitors connected to the same network no longer monitoring patient vitals and

staffing levels not able to monitor all patient vitals).

FDA recommends that manufacturers address how their device(s) and the system(s) in which

they operate defend against and/or respond to attacks with the potential to harm multiple patients

in a multi-patient harm view. This view should include the information recommended in

Appendix 2. These risks, once identified, may also need to be assessed differently in the

accompanying cybersecurity risk assessment due to the different nature of the risk.

With the need to provide timely, reliable updates to devices in order to address emerging

cybersecurity risks throughout the TPLC of the device, FDA recommends manufacturers provide

an updateability and patchability view. This view should describe the end-to-end process that

permits software updates and patches to be provided (i.e., deployed) to the device, and should

include detailed information as recommended in Appendix 2.

For example, if a device manufacturer intends to push software from a software update server to

an in-clinic cardiac implant programmer, “end-to-end” means the path from the update server to

the in-clinic programmer that programs the implanted device. The software update path will

likely include traversing technology that the device manufacturer does not control, and therefore

the device design should provide for the protection of the end-to-end path and take into account

any additional cybersecurity risk created or posed by those non-manufacturer-controlled

technologies.

(d) Security Use Case Views

In addition to the views identified above, security use case views should also be provided.

Security use cases should be included for all medical device system functionality through which

a security compromise could impact the safety or effectiveness of the device. These security use

cases should cover various operational states of elements in the medical device system (e.g.,

power on, standby, transition states) and assess clinical functionality states of the medical device

system (e.g., programming, alarming, delivering therapy, send/receive data, reporting diagnostic

results).

The number of security use cases that should be assessed will scale with the cybersecurity

complexity and risk of the device. Each view should include detailed information as

recommended in Appendix 2. For use cases identified that share the same security assessment,

the associated diagrams and explanatory text can describe the multiple use cases covered by the

view in lieu of providing duplicative information in multiple places. For example, programming

commands and sending/receiving device data may share the same communication protocol and

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therefore may not exhibit differences between the security views for both scenarios, despite

having different clinical risk assessments.

C. Cybersecurity Testing

As with other areas of product development, testing is used to demonstrate the effectiveness of

design controls. While software development and cybersecurity are closely related disciplines,

cybersecurity controls require testing beyond standard software verification and validation

activities to demonstrate the effectiveness of the controls in a proper security context to therefore

demonstrate that the device has a reasonable assurance of safety and effectiveness.

Under 21 CFR 820.30(f), a manufacturer must establish and maintain procedures for verifying

the device design. Such verification shall confirm that the design output meets the design input

requirements. Under 21 CFR 820.30(g), a manufacturer must establish and maintain procedures

for validating its device design. Such design validation shall include software validation and risk

analysis, where appropriate. FDA recommends verification and validation include sufficient

testing performed by the manufacturer on the cybersecurity of the medical device system through

which the manufacturer verifies and validates their inputs and outputs, as appropriate.

Security testing documentation and any associated reports or assessments should be submitted in

the premarket submission. FDA recommends that the following types of testing, among others,

be considered for inclusion in the submission:

• Security requirements;

• Manufacturers should provide evidence that each design input requirement was

implemented successfully.

• Manufacturers should provide evidence of their boundary analysis and rationale

for their boundary assumptions.

• Threat mitigation;

• Manufacturers should provide details and evidence of testing that demonstrates

effective risk control measures according to the threat models provided in the

global system, multi-patient harm, updatability and patchability, and security use

case views.

• Manufacturers should ensure the adequacy of each cybersecurity risk control

(e.g., security effectiveness in enforcing the specified security policy,

performance for maximum traffic conditions, stability, and reliability, as

appropriate).

• Vulnerability Testing (such as section 9.4 of ANSI/ISA 62443-4-1); and

• Manufacturers should provide details and evidence

of the following testing and

analyses:

• Abuse or misuse cases, malformed and unexpected inputs;

• Robustness.

• Fuzz testing.

For any testing tools or software used, the details provided may include, but may not be limited to, the name of the

tool, version information as applicable, and any settings or configuration options for the tools used.

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• Attack surface analysis;

• Vulnerability chaining;

• Closed box testing of known vulnerability scanning;

• Software composition analysis of binary executable files; and

• Static and dynamic code analysis, including testing for credentials that are

“hardcoded,” default, easily guessed, and easily compromised.

• Penetration testing;

• The testing should identify and characterize security-related issues via tests that

focus on discovering and exploiting security vulnerabilities in the product.

Penetration test reports should be provided and include the following elements:

• Independence and technical expertise of testers;

• Scope of testing;

• Duration of testing;

• Testing methods employed; and

• Test results, findings, and observations.

Device manufacturers should indicate in the test reports by whom the testing was performed

(e.g., independent internal testers, external testers) and what level of independence those

responsible for testing devices have from the developers responsible for designing devices. In

some cases, it may be necessary to use third parties to ensure an appropriate level of

independence between the two groups, such that vulnerabilities or other issues revealed during

testing are appropriately addressed. For any third-party test reports, manufacturers should

provide the original third-party report. For all testing, manufacturers should provide their

assessment of any findings including rationales for not implementing or deferring any findings to

future releases.

As discussed in Sections V.A.2. and V.A.3. above, vulnerabilities and anomalies identified

during testing should be assessed for their security impacts as part of the security risk

management process. In non-security software testing, a benefit analysis of a discovered defect

may lead to the conclusion that an anomaly does not need to be fixed, as its impact on medical

device system functionality may be small or unlikely. Conversely, in security testing, the

exploitability of an anomaly may necessitate that it is mitigated because of the greater, and

different type of, harm that it could facilitate.

For issues that will be addressed in future releases (i.e., remediation deferred for a future

software release because current risk was assessed to be acceptable), the premarket submission

should contain plans for those releases. Such plans should include the vulnerabilities that future

software releases will address, anticipated timelines for release, whether devices released in the

interim will receive those updates, and how long it will take the update to reach the devices.

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There are numerous authoritative resources for outlining security testing that may partially fulfill

the testing outlined above.

FDA recommends that cybersecurity testing should occur throughout the SPDF. Security testing

early in development can ensure that security issues are addressed prior to impacting release

timelines and can prevent the need to redesign or re-engineer the device. After release,

cybersecurity testing should be performed at regular intervals commensurate with the risk (e.g.,

annually) to ensure that potential vulnerabilities are identified and able to be addressed prior to

their ability to be exploited.

VI. Cybersecurity Transparency

In order for users to manage security risks in medical device systems, either by an end user or

within a larger risk management framework like the NIST CSF, transparency is critical to ensure

safe and effective use and integration of devices and systems. This transparency can be conveyed

through both device labeling and the establishment of manufacturer vulnerability management

plans. However, different types of users (e.g., manufacturers, servicers, patients) will have

different abilities to take on a mitigation role, and the need for actions to ensure continued

cybersecurity should be appropriate for the type of user.

A. Labeling Recommendations for Devices with

Cybersecurity Risks

FDA regulates device labeling in several ways. For example, section 502(f) of the FD&C Act

requires that labeling include adequate directions for use. Under section 502(a)(1) of the FD&C

Act, a medical device is deemed misbranded if its labeling is false or misleading in any

particular.

For devices with cybersecurity risks, informing users of relevant security information may be an

effective way to comply with labeling requirements relating to such risks. FDA also believes that

informing users of security information through labeling may be an important part of design and

development activities to help mitigate cybersecurity risks and help ensure the continued safety

and effectiveness of the device. Therefore, when drafting labeling for inclusion in a premarket

submission, a manufacturer should consider all applicable labeling requirements and how

informing users through labeling may be an effective way to manage cybersecurity risks and/or

to ensure the safe and effective use of the device. Any risks transferred to the user should be

detailed and considered for inclusion as tasks during usability testing (e.g., human factors

testing)

to ensure that the type of user has the capability to take appropriate actions to manage

those risks.

The following standards may partially meet the security testing recommendations: ANSI/UL 2900 Software

Cybersecurity for Network-Connectable Products, ANSI/ISA 62443-4-1 Security for industrial automation and

control systems Part 4-1: Product security development life-cycle requirements, in addition to IEC 81001-5-1.

Additional standards may also meet or partially meet the testing recommendations outlined in this section.

See FDA’s Guidance “Applying Human Factors and Usability Engineering to Medical Devices,” available at

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-

engineering-medical-devices

Contains Nonbinding Recommendations

The recommendations below aim to communicate to users the relevant device security

information that may enable their own ongoing security posture, thereby helping ensure a device

remains safe and effective throughout its lifecycle. The depth of detail, the exact location in the

labeling for specific types of information (e.g., operator’s manual, security implementation

guide), and the method to provide this information should account for the intended user of the

information. Instructions to manage cybersecurity risks should be understandable to the intended

audience, which might include patients or caregivers with limited technical knowledge. The

manufacturer may wish to employ methods to ensure certain information is available only to the

user, and if it does so through an online portal, should ensure that users have up-to-date links that

contain accurate information.

The following are examples of information that may be included in labeling to communicate

relevant security information to users:

• Device instructions and product specifications related to recommended cybersecurity

controls appropriate for the intended use environment (e.g., anti-malware software, use of

a firewall, password requirements).

• Sufficiently detailed diagrams for users that allow recommended cybersecurity controls

to be implemented.

• A list of network ports and other interfaces that are expected to receive and/or send data.

This list should include a description of port functionality and indicate whether the ports

are incoming, outgoing, or both, along with approved destination end-points.

• Specific guidance to users regarding supporting infrastructure requirements so that the

device can operate as intended (e.g., minimum networking requirements, supported

encryption interfaces). Where appropriate, such guidance should include technical

instructions to permit secure network deployment and servicing, and instructions for

users on how to respond upon detection of a cybersecurity vulnerability or incident.

• An SBOM as specified in Section V.A.4. or in accordance with an industry accepted

format to effectively manage their assets, to understand the potential impact of identified

vulnerabilities to the medical device system, and to deploy countermeasures to maintain

the device’s safety and effectiveness. Manufacturers should provide or make available

SBOM information to users on a continuous basis. If an online portal is used,

manufacturers should ensure that users have up-to-date links that contain accurate

information. The SBOM should be in a machine-readable format.

• A description of systematic procedures for users to download version-identifiable

manufacturer-authorized software and firmware, including a description of how users

will know when software is available.

• A description of how the design enables the device to respond when anomalous

conditions are detected (i.e., security events). This should include notification to the user

and logging of relevant information. Security event types could be configuration changes,

For more information regarding FDA’s policy on labeling changes and submission requirements, manufacturers

can use the FDA Guidance Search Tool to identify relevant guidance documents for their product and submission

type, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/

See IEC TR 80001-2-2 and IEC TR 80001-2-8 and IEC TR 80001-2-9 for further labeling information for

compliance with these standards.

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network anomalies, login attempts, or anomalous traffic (e.g., send requests to unknown

entities).

• A high-level description of the device features that protect critical functionality (e.g.,

backup mode, disabling ports/communications).

• A description of backup and restore features and procedures to restore authenticated

configurations.

• A description of methods for retention and recovery of device configuration by an

authenticated authorized user.

• A description of the secure configuration of shipped devices, instructions for user-

configurable changes, and identification of user-configurable changes that could increase

security risk for the medical device system. Secure configurations may include end point

protections such as anti-malware, firewall/firewall rules, allow lists, deny lists, security

event parameters, logging parameters, and physical security detection, and resetting of

credentials, among others.

• Where appropriate for the intended use environment, a description of how forensic

evidence is captured, including but not limited to any log files kept for a security event.

Log file descriptions should include how, where, and in what format the log file is

located, stored, recycled, archived, and how it could be consumed by automated analysis

software (e.g., Intrusion Detection System (IDS) or Security Information and Event

Management (SIEM)).

• Information, if known or anticipated, concerning device cybersecurity (including

components) end of support and end of life. At the end of support, a manufacturer may no

longer be able to reasonably provide security patches or software updates. If the device

remains in service following the end of support, the manufacturer should have a pre-

established and pre-communicated process for transferring the risks highlighting that the

cybersecurity risks for end-users can be expected to increase over time.

• Information on securely decommissioning devices by sanitizing the product of sensitive,

confidential, and proprietary data and software.

A revision-controlled, Manufacturer Disclosure Statement for Medical Device Security

(MDS2)

and Customer Security Documentation as outlined in the Medical Device and Health

IT Joint Security Plan (JSP)

may address a number of the above recommendations.

B. Cybersecurity Management Plans

Recognizing that cybersecurity risks evolve as technology evolves throughout a device’s TPLC,

FDA recommends that manufacturers establish a plan for how they will identify and

communicate to users vulnerabilities that are identified after releasing the device in accordance

with the 21 CFR 820.100. This plan can also support security risk management processes that are

described throughout the QS regulation.

FDA recommends that manufacturers submit their cybersecurity management plans as part of

their premarket submissions so that FDA can assess whether the manufacturer has sufficiently

The Manufacturer Disclosure Statement for Medical Device Security is available at

https://www.nema.org/standards/view/manufacturer-disclosure-statement-for-medical-device-security

Available at https://healthsectorcouncil.org/the-joint-security-plan/

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addressed how to maintain the safety and effectiveness of the device after marketing

authorization is achieved. For cyber devices, “a plan to monitor, identify, and address, as

appropriate, in a reasonable time, postmarket cybersecurity vulnerabilities and exploits,

including coordinated vulnerability disclosure and related procedures” is required (see section

524B(b)(1) of the FD&C Act).

Cybersecurity management plans should include the following elements:

• Personnel responsible;

• Sources, methods, and frequency for monitoring and identifying vulnerabilities (e.g.,

researchers, NIST national vulnerability database (NIST NVD), third-party software

manufacturers);

• Identify and address vulnerabilities identified in CISA Known Exploited Vulnerabilities

Catalog;

• Periodic security testing;

• Timeline to develop and release patches;

• Update processes;

• Patching capability (i.e., rate at which update can be delivered to devices);

• Description of their coordinated vulnerability disclosure process; and

• Description of how the manufacturer intends to communicate forthcoming remediations,

patches, and updates to customers.

Additional recommendations on coordinated vulnerability disclosure plans may be found in

FDA’s Postmarket Cybersecurity Guidance.

Available at https://www.cisa.gov/known-exploited-vulnerabilities-catalog

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Appendix 1. Security Control Categories and Associated

Recommendations

The following sections provide detailed descriptions of each of the security control categories

introduced in Section V.B.1., as well as specific recommendations for security controls and their

implementation, to avoid common pitfalls.

Authentication

There are generally two types of authentication controls—information and entities—and a

properly-secured system is able to prove the existence of both.

Authentication of information

exists where the device and the system in which it operates are

able to prove that information originated at a known and trusted source, and that the information

has not been altered in transit between the original source and the point at which authenticity is

verified. It is important to note that while authenticity implies that data is accurate and has been

safeguarded from unauthorized user modification (i.e., integrity), integrity alone does not

provide assurance that the data is real and came from a trusted source. Therefore, for the

purposes of this guidance, authentication is discussed as a larger security objective over integrity.

Authentication of entities exists where a device and the system in which it operates is able to

prove the identity of an endpoint (whether hardware and/or software) from which it is sending

and/or receiving information, or authorized user/operator at that endpoint.

As part of normal operations within a secure system, devices should verify the authenticity of

information from external entities, as well as prove the authenticity of information that they

generate. A medical device system that appropriately accounts for authenticity can evaluate and

ensure authenticity for:

• Information at rest (stored);

• Information in transit (transmitted);

• Entity authentication of communication endpoints, whether those endpoints consist of

software or hardware;

• Software binaries;

• Integrity of the execution state of currently running software; and

• Any other appropriate parts of the medical device system where a manufacturer’s threat

model and/or risk analyses reveal the need for it.

On a technical level, the strength of a device’s authentication scheme is defined by the amount of

effort, including time, that an unauthorized party would need to expend to identify the

decomposition of the authentication scheme. For example, this could be the time and resources

necessary to determine the correct “output” of a cryptographic function from which a

cryptographically-based authentication scheme is built and which an unauthorized party could

use to bypass the authentication scheme and gain access to the medical device system.

For the purposes of this control, “information” includes the software/firmware itself, as well as input and output

data.

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When choosing an authentication scheme, manufacturers should keep in mind the following

generally applicable characteristics of different types of schemes:

• Implicit authentication schemes, based solely on non-cryptographic interfaces,

handshakes, and/or protocols, are inherently weak because, once they are reverse-

engineered, an unauthorized user can easily emulate the correct behavior and appear to be

authorized.

• Cryptographic authentication protocols are generally superior, but they need careful

design choices and implementation practices to achieve their full strength.

In addition, these schemes are still limited by the confidentiality of the cryptographic keys

needed to interact with the scheme, and by the integrity of the devices that hold or otherwise

leverage those keys. For more information on cryptography, see Appendix 1 subsection C.,

below. Therefore, for device operations where non-authenticated behavior could lead to harm,

devices should implement additional, non-routine signals of intent based on physical actions,

such as a momentary switch, to authorize the command/session.

The following list provides additional recommendations for the implementation of authentication

schemes:

• Use cryptographically strong

authentication, where the authentication functionality

resides on the device, to authenticate personnel, messages, commands updates, and as

applicable, all other communication pathways. Hardware-based security solutions should

be considered and employed when possible;

• Authenticate external connections at a frequency commensurate with the associated risks.

For example, if a device connects to an offsite server, then the device and the server

should mutually authenticate each session and limit the duration of the session, even if

the connection is initiated over one or more existing trusted channels;

• Use appropriate user authentication (e.g., multi-factor authentication to permit privileged

device access to system administrators, service technicians, or maintenance personnel,

among others, as needed);

• Require authentication, and authorization in certain instances, before permitting software

or firmware updates, including those updates affecting the operating system, applications,

and anti-malware functionality;

• Strengthen password protections. Do not use passwords that are hardcoded, default,

easily guessed, or easily compromised (e.g., passwords that are the same for each device;

unchangeable; can persist as default; difficult to change; and/or vulnerable to public

disclosure);

• Implement anti-replay measures in critical communications such as potentially harmful

commands. This can be accomplished with the use of several methods including the use

of cryptographic nonces (an arbitrary number used only once in a cryptographic

communication);

See the definition of security strength in Appendix 5, Terminology.

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• Provide mechanisms for verifying the authenticity of information originating from the

device, such as telemetry. This is especially important for data that, if spoofed or

otherwise modified, could result in patient harm, such as the link between a clinician

programmer or monitoring device and an implanted device like a pacemaker,

defibrillator, or neurostimulator; or the link between a continuous glucose monitor system

and an automated insulin pump;

• Do not rely on cyclic redundancy checks (CRCs) as security controls. CRCs do not

provide integrity or authentication protections in a security environment. While CRCs are

an error detecting code and provide integrity protection against environmental factors

(e.g., noise or EMC), they do not provide protections against an intentional or malicious

actor; and

• Consider how the device and/or system should respond in event of authentication

failure(s).

Authorization

For the purposes of this guidance, authorization is the right or a permission that is granted to a

system entity (e.g., a device, server, or software function) to access a system resource. More

specifically, as a defensive measure, an authorization scheme enforces privileges (i.e., “rights”

associated with authenticated sessions, identities and/or roles). These privileges either permit

allowed behavior, or refuse disallowed behavior in order to ensure that system resources are only

accessed in accepted ways, by accepted parties.

Within an adequately designed authorization scheme, the principle of least privileges

should be

applied to users, system functions, and others, to only allow those entities the levels of system

access necessary to perform a specific function.

For example, in a situation in which a malicious actor has gained access to a credential

associated with patient privileges, that malicious actor should not be able to access device

resources or functionality reserved for the manufacturer or for the healthcare provider, such as

device maintenance routines or the ability to change medication dosage amounts.

While authentication schemes based on cryptographically proven designs are generally

considered more robust and are therefore preferred, meaningful authorization checks can be

performed based on other compelling evidence (e.g., benefit/risk assessment in accordance with

Section 6.5 of AAMI TIR57 and associated supporting justification and as evidenced through

security testing). For example, a medical device programmer that is capable of Near-Field

Communications (NFC) could have elevated privileges that are granted based on a signal of

intent

over NFC that cannot physically be produced by another unauthorized device over

Radio-Frequency (RF) (e.g., a home monitor).

The following list provides recommended design implementations for an authorization scheme:

CNSSI 4009-2015 defines “least privilege” as “The principle that a security architecture should be designed so

that each entity (e.g., user, asset) is granted the minimum system resources and authorizations that the entity needs

to perform its function.”

For the purposes of this guidance, “signal of intent” is specific to the implementation of NFC communications.

Contains Nonbinding Recommendations

• Limit authorized access to devices through the authentication of users (e.g., user ID and

password, smartcard, biometric, certificates, or other appropriate authentication method);

• Use automatic timed methods to terminate sessions within the medical device system

where appropriate for the use environment;

• Employ an authorization model that incorporates the principle of least privileges by

differentiating privileges based on the user role (e.g., caregiver, patient, healthcare

provider, system administrator) or device functions; and

• Design devices to “deny by default” (i.e., that which is not expressly permitted by a

device is denied by default). For example, the device should generally reject all

unauthorized connections (e.g., incoming TCP, USB, Bluetooth, serial connections).

Ignoring requests is one form of denying authorization.

Cryptography

Cryptographic algorithms and protocols are recommended to be implemented to achieve the

secure by design objectives outlined in Section IV. While high-quality, standardized

cryptographic algorithms and protocols are readily available, several commercial products that

include cryptographic protections have been shown to have exploitable vulnerabilities due to

improper configurations and/or implementations.

While other sections of this guidance reference cryptographic controls, the following

recommendations are specifically related to the selection and implementation of the underlying

cryptographic scheme used by a device and the larger system in which it operates:

• Select industry-standard cryptographic algorithms and protocols, and select appropriate

key generation, distribution, management and protection, as well as robust nonce

mechanisms.

• Use current NIST recommended standards for cryptography (e.g., FIPS 140-3,

NIST

Suite B

), or equivalent-strength cryptographic protection that are expected to be

considered cryptographically strong throughout the service life of the device.

• Manufacturers should not implement cryptographic algorithms that have been

deprecated or disallowed in applicable standards or best practices (e.g., NIST SP

800-131A, Transitioning the Use of Cryptographic Algorithms and Key Lengths).

Implementation of algorithms with a status of “legacy use” should be discussed

with FDA during a pre-submission meeting.

• Design a system architecture and implement security controls to prevent a situation where

the full compromise of any single device can result in the ability to reveal keys for other

devices.

• For example, avoid using master-keys stored on device, or key derivation

algorithms based solely on device identifiers or other readily discoverable

information.

NIST FIPS 140-3 Cryptographic Module Validation Program available at

https://csrc.nist.gov/Projects/cryptographic-module-validation-program/fips-140-2

NIST FIPS 140-2 Suite B available at https://csrc.nist.gov/CSRC/media/projects/cryptographic-module-

validation-program/documents/security-policies/140sp2851.pdf

Contains Nonbinding Recommendations

• For example, avoid using device serial numbers as keys or as part of keys. Device

serial numbers may be disclosed by patients seeking additional information on

their device or might be disclosed during a device recall to identify affected

products and should be avoided as part of the key generation process (e.g., public-

key cryptography can be employed to help meet this objective).

• Implement cryptographic protocols that permit negotiated parameters/versions such that

the most recent, secure configurations are used, unless otherwise necessary.

• Do not allow downgrades, or version rollbacks, unless absolutely necessary for safety

reasons, and log and document the event. Downgrades can allow attackers to exploit

prior, less protected versions and should be avoided.

Code, Data, and Execution Integrity

Many cybersecurity incidents are caused, at their root, by the violation of some form of device

integrity. This includes the violation of stored code, stored and operational data, or execution

state. The following recommendations are provided to address each of these categories.

• Code Integrity

• Hardware-based security solutions should be considered and employed when

possible;

• Authenticate firmware and software. Verify authentication tags (e.g., signatures,

message authentication codes (MACs)) of software/firmware content, version

numbers, and other metadata. The version numbers intended to be installed should

themselves be signed or have MACs. Devices should be electronically and visibly

identifiable (e.g., Unique device identifier (UDI),

model number, serial

number);

• Allow installation of cryptographically authenticated firmware and software

updates, and do not allow installation where such cryptographic authentication

either is absent or fails. Use cryptographically signed updates to help prevent any

unauthorized reductions in the level of protection (downgrade or rollback attacks)

by ensuring that the new update represents an authorized version change;

• One possible approach for authorized downgrades would be to sign new

metadata for downgrade requests which, by definition, only happen in

exceptional circumstances.

• Ensure that the authenticity of software, firmware, and configuration are validated

prior to execution, e.g., “allow-listing”

based on digital signatures;

• Disable or otherwise restrict unauthorized access to all test and debug ports (e.g.,

JTAG, UART) prior to delivering products; and

• Employ tamper evident seals on device enclosures and their sensitive

communication ports to help verify physical integrity.

For more information regarding UDI, see FDA’s webpage https://www.fda.gov/medical-devices/unique-device-

identification-system-udi-system/udi-rule-guidances-training-and-other-resources

For the purposes of this guidance, “allow-list” means a list of discrete entities, such as hosts or applications that

are known to be benign and are approved for use within an organization and/or information system. This term is

leveraged from the definition of “whitelist” in NIST SP 800-128, available at

https://csrc.nist.gov/pubs/sp/800/128/upd1/final

Contains Nonbinding Recommendations

• Data Integrity

• Verify the integrity of all incoming data, ensuring that it is not modified in transit

or at rest. Cryptographic authentication schemes verify data integrity, but do not

verify data validity. Therefore, the integrity of all incoming data should be

verified to ensure that it is not modified in transit or at rest;

• Validate that all data originating from external sources is well-formed and

compliant with the expected protocol or specification. Additionally, as

appropriate, validate data ranges to ensure they fall within safe limits; and

• Protect the integrity of data necessary to ensure the safety and effectiveness of the

device, e.g., critical configuration settings such as energy output.

• Execution Integrity

• Use industry-accepted best practices to maintain and verify integrity of code

while it is being executed on the device. For example, Host-based Intrusion

Detection/Prevention Systems (HIDS/HIPS) can be used to accomplish this goal;

and

• Carefully design and review all code that handles the parsing of external data

using automated (e.g., static and dynamic analyses) and manual (i.e., code review)

methods.

Confidentiality

Manufacturers should ensure support for the confidentiality

of any/all data whose disclosure

could lead to patient harm (e.g., through the unauthorized use of otherwise valid credentials, lack

of encryption). Loss of confidentiality of credentials could be used by a threat-actor to effect

multi-patient harm. Lack of encryption to protect sensitive information and or data at rest and in

transit can expose this information to misuse that can lead to patient harm. For example,

confidentiality is required in the handling and storage of cryptographic keys used for

authentication because disclosure could lead to unauthorized use/abuse of device functionality.

The proper implementation of authorization and authentication schemes as described in Sections

A. and B. of this appendix will generally assure confidentiality. However, manufacturers should

evaluate and assess whether this is the case during their threat modeling and other risk

management activities and make any appropriate changes to their medical device systems to

ensure appropriate confidentiality controls are in place.

Event Detection and Logging

Event detection and logging are critical capabilities that should be present in a device and the

larger system in which it operates in order to ensure that suspected and successful attempts to

compromise a medical device may be identified and tracked. These event detection capabilities

For the purposes of this guidance, loss of confidential health information is generally not considered to be a direct

impact on safety and effectiveness. Although protecting the confidentiality of PHI is beyond the scope of this

document, it should be noted that manufacturers and other entities, depending on the facts and circumstances, may

be obligated to protect the confidentiality, integrity and availability of PHI throughout the product lifecycle, in

accordance with applicable federal and state laws, including the Health Insurance Portability and Accountability Act

(HIPAA). For more information on HIPAA, please visit

https://www.hhs.gov/hipaa/for-professionals/security/laws-

regulations/index.html

Contains Nonbinding Recommendations

and logs should include storage capabilities, if possible, so that forensic discovery may later be

performed.

While many of the following recommendations are tailored for workstations, the concepts

presented below also apply to embedded computing devices. Manufacturers should consider the

following for all devices:

• Implement design features that allow for security compromises and suspected

compromise attempts to be detected, recognized, logged, timed, and acted upon during

normal use. Acting upon security events should consider the benefit/risk assessment in

accordance with Section 6.5 of AAMI TIR57 in determining whether it is appropriate to

affect standard device functionality during a security event.

• Ensure the design enables forensic evidence capture.

The design should include

mechanisms to securely create and store log files off the device to track security events.

Documentation should include how and where log files are located, stored, recycled,

archived, and how they could be consumed by automated analysis software (e.g.,

Intrusion Detection System (IDS)). Examples of security events include, but are not

limited to, configuration changes, network anomalies, login attempts, and anomalous

traffic (e.g., sending requests to unknown entities).

• Design devices such that the potential impact of vulnerabilities is limited by specifying a

secure configuration. Secure configurations may include endpoint protections, such as

anti-malware, firewall/firewall rules, allow-listing, defining security event parameters,

logging parameters, physical security detection, and/or HIDS/HIPS.

• Design devices such that they may integrate and/or leverage antivirus/anti-malware

protection capabilities. These capabilities may vary depending on the type of device and

the software and hardware components it contains:

• For devices that leverage Windows Operating System:

• Antivirus/anti-malware is recommended on the device. Manufacturers are

recommended to qualify multiple options to support user preferences for

different options, especially if the device is used in healthcare facility

environments.

• For devices that leverage other Commercial Operating Systems (e.g., Ubuntu,

Unix, Linux, Apple, Android):

• Antivirus/anti-malware may be recommended based on the environment

and associated risks of the device. Different operating systems will likely

follow a case-by-case determination based on network exposure and risk.

• For devices that leverage Embedded Operating Systems (e.g., Real-Time

Operating Systems, Windows embedded):

• Antivirus/malware detection/protection software is generally not needed

unless a particular risk or threat is identified that would not be addressed

by other expected security controls.

Forensic evidence capture is a necessary part of digital forensics. NIST SP 800-86 available at

https://nvlpubs.nist.gov/nistpubs/Legacy/SP/nistspecialpublication800-86.pdf defines digital forensics as “The

application of science to the identification, collection, examination, and analysis, of data while preserving the

integrity of the information and maintaining a strict chain of custody for the data.”

Contains Nonbinding Recommendations

• Design devices to enable software configuration management and permit tracking and

control of software changes to be electronically obtainable (i.e., machine readable) by

authorized users.

• Design devices to facilitate the performance of variant analyses such that the same

vulnerabilities can be identified across device models and product lines.

• Design devices to notify users when malfunctions or anomalous device behavior,

including those potentially related to a cybersecurity breach, are detected.

• Consider designing devices such that they are able to produce a SBOM in a machine

readable

format.

Resiliency and Recovery

Devices should be designed to be resilient to possible cyber incident scenarios (also known as

“cyber-resiliency”) and maintain availability. Cyber-resiliency capabilities are important for

medical devices because they provide a safety margin against unknown future vulnerabilities.

The following recommendations are intended to help designers achieve cyber-resiliency:

• Implement features that protect critical functionality and data, even when the device has

been partially compromised. For example, process isolation, virtualization techniques,

and hardware-backed trusted execution environments all provide mechanisms to

potentially contain the impact of a successful exploitation of a device.

• Design devices to provide methods for retention and recovery of trusted default device

configuration by an authenticated, authorized user.

• Design devices to specify the level of resilience, or independent ability to function, that

any component of the medical device system possesses when its communication

capabilities with the rest of the medical device system are disrupted, including disruption

of significant duration.

• Design devices to be resilient to possible cyber incident scenarios such as network

outages, Denial of Service,

excessive bandwidth usage by other products, disrupted

quality of service (QoS),

and/or excessive jitter

(i.e., a variation in the delay of

received packets).

• Design devices to be resilient to possible noise items (e.g., scanning).

Firmware and Software Updates

Devices should be capable of being updated in a secure and timely manner to maintain safety and

effectiveness throughout the product’s lifecycle. Despite best efforts, undiscovered, exploitable

vulnerabilities may exist in devices after they are marketed. This is especially true over the

Recommendation 2.2 from the Health Care Industry and Cybersecurity Task Force (HCIC TF) Report on

Improving Cybersecurity in the Health Care Industry available at

https://www.phe.gov/Preparedness/

planning/CyberTF/Documents/report2017.pdf

Denial of Service is an attack that prevents or impairs the authorized use of the information system, resources, or

services.

From CNSSI 4009 Committee on National Security Systems (CNSS) Glossary.

From NIST Computer Security Resource Center Glossary available at https://csrc.nist.gov/glossary/term/jitter

Contains Nonbinding Recommendations

device’s service life, as threats evolve over time and exploit methods change, and become more

sophisticated.

FDA recommends that manufacturers should not only build in the ability for devices to be

updated, but that manufacturers also plan for the rapid testing, evaluation, and patching of

devices deployed in the field. The following recommendations can help to achieve this:

• Design devices to anticipate the need for software and firmware patches and updates to

address future cybersecurity vulnerabilities. This will likely necessitate the need for

additional storage space and processing resources.

• Consider update process reliability and how update process works in event of

communication interruption or failure. This should include both considerations for

hardware impacts (timing specifics of interruptions) and which phase of the update

process the interruption or failure occurs.

• Consider cybersecurity patches and updates that are independent of regular feature update

cycles.

• Implement processes, technologies, security architectures, and exercises to facilitate the

rapid verification, validation, and distribution of patches and updates.

• Preserve and maintain full build environments and virtual machines, regression test

suites, engineering development kits, emulators, debuggers, and other related tools that

were used to develop and test the original product to ensure updates and patches may be

applied safely and in a timely manner.

• Maintain necessary third-party licenses throughout the supported lifespan of the device.

Develop contingency plans for the possibility that a third-party company goes out of

business or stops supporting a licensed product. Modular designs should be considered

such that third-party solutions could be readily replaced.

• Implement a secure process and mechanism for providing validated software updates and

patches for users.

Contains Nonbinding Recommendations

Appendix 2. Submission Documentation for Security

Architecture Flows

In premarket submissions, FDA recommends that manufacturers provide detailed information for

the views identified in Section V.B.2. Methods for providing the views and the recommendations

for the level of detail to provide are discussed in the sections below. In addition to diagrams and

explanatory text, call-flow views can be provided to convey some of the information details

expected to be addressed in the architecture views.

A. Diagrams

FDA recommends that manufacturers provide diagrams to help describe the medical device

system architecture, interfaces, communication protocols, threats, and cybersecurity controls

used throughout the system. Different diagramming methods can be used to describe the

architecture, including data flow diagrams, state diagrams, swim-lane diagrams, and call-flow

diagrams, among others. Architecture views should include diagram(s) with explanatory text that

describes the sequence of process or protocol steps in explicit detail for an associated use case.

Architecture views should provide specific protocol details of the communication pathways

between parts of the medical device system, to include authentication or authorization

procedures and session management techniques. These views should be sufficiently detailed such

that engineers and reviewers should be able to logically and easily follow data, code, and

commands from any asset (e.g., a manufacturer server) to any other associated asset (e.g., a

medical device), while possibly crossing intermediate assets (e.g., application). The diagrams

may also include items from the information details identified below for the architecture views

identified in Section V.B.2. if the information is better represented or conveyed through a

diagram than explanatory text alone.

B. Information Details for an Architecture View

For each view described in Section V.B.2., manufacturers should provide a system-level

description and analysis inclusive of end-to-end security analyses of all the communications in

the medical device system regardless of intended use. This should include detailed diagrams and

traces for all communication paths as described below. Security-relevant analysis requires the

ability to construct and follow a detailed trace for important communication paths, which

describes how data, code, and commands are protected between any two assets in the medical

device system. This analysis can also help identify the software that should be included in the

SBOM for each device.

The FDA recommends that security architecture views should consider the following examples

of information for inclusion:

• Detailed diagrams and supporting explanatory text that identify all medical device system

assets, including but not limited to:

• Device hardware itself (including assessments for any commercial platforms);

Contains Nonbinding Recommendations

• Applications, hardware, and/or other supporting assets that directly interact with

the targeted device, such as configuration, installation/upgrade, and data transfer

applications;

• Healthcare facility-operated assets;

• Communications/networking assets; and

• Manufacturer-controlled assets, including any servers that interact with external

entities (e.g., a service that collects and redistributes device data, or a firmware

update server).

• For every communication path that exists between any two assets in the security use case

view (and/or explanatory text), including indirect connections when there is at least one

intermediate asset (e.g., an app), the following details should be provided:

• A list of the communication interfaces and paths, including communication paths

(e.g., between two assets through an intermediary), and any unused interfaces;

• An indication of whether the path is used for data, code, and/or commands, and

type of data/information/code being transferred;

• Protocol name(s), version number(s), and ports/channels/frequencies;

• Detailed descriptions of the primary and all available functionality for each

medical device system asset, including assessment of any functionality that is

built in but not currently used or enabled (e.g., dormant application functionality

or ports), including assurance that this functionality cannot be activated and/or

misused;

• Access control models or features (if any) for every asset (such as privileges, user

accounts/groups, passwords);

• Users’ roles and levels of responsibility if they interact with the assets and

communication channels;

• Any “handoff” sequences from one communication path to another (e.g., from

asset to asset, network to network, or Bluetooth to Wi-Fi), and how the data, code,

and/or commands are secured/protected during handoff (i.e., how is their

integrity/authenticity assured);

• Explanations of intended behavior in unusual/erroneous/unexpected

circumstances (e.g., termination of a connection in the middle of a data transfer);

• Authentication mechanism (if any), including the algorithm name/version (if

available), “strength” indicators (e.g., key bit length, number of computational

rounds) and mode of operation (if applicable);

• Descriptions of the cryptographic method used and the type and level of

cryptographic key usage and their style of use throughout the medical device

system (e.g., one-time use, key length, the standard employed, symmetric or

otherwise). Descriptions should also include details of cryptographic protection

for firmware and software updates;

• Detailed analyses by cryptography experts if a cryptography algorithm is

proprietary, or a proprietary modification of a standard algorithm;

• For each authenticator created, a list of where it is verified, and how verification

credentials (e.g., certificates, asymmetric keys, or shared keys) are distributed to

both endpoints;

Contains Nonbinding Recommendations

• A precise, detailed list of how each type of credential (e.g., password, key) is

generated, stored, configured, transferred, and maintained, including both

manufacturer- and healthcare facility-controlled assets (e.g., key management and

public key infrastructure (PKI));

• Identity management83 (if any), including how identities are managed/transferred

and configured (e.g., from manufacturer to programmer and from programmer to

device);

• If communication sessions are used or supported, a detailed explanation of how

sessions are established, maintained, and broken down, including but not limited

to assurances of security properties such as uniqueness, unpredictability, time-

stamping, and verification of session identifiers;

• Include any security configuration settings and their default values;

• Precise links between diagram elements (or explanatory text), associated hazards

and controls, and testing;

• Explanations or links to the evidence that may be used to justify security claims

and any assumptions; and

• Traceability of the asset to the SBOM component described in Section V.B.2.,

above, for proprietary and third-party code, when appropriate.

For the purposes of this guidance, “identity management” means the process that governs the authentication and

authorization of users to devices and assets.

Contains Nonbinding Recommendations

Appendix 3. Submission Documentation for Investigational

Device Exemptions

FDA understands the need to balance innovation and security in designs especially during

clinical trials. In order to ensure security is addressed early in the device design, FDA has

identified a subset of the documentation recommended throughout this guidance to submit with

IDE applications.

Under 21 CFR 812.25, manufacturers must provide an investigational plan as a part of their IDE

application. For investigational devices within the scope of this guidance, FDA recommends that

this investigational plan include information on the cybersecurity of the subject device.

Specifically, FDA recommends the following documentation be included as part of IDE

applications:

• Inclusion of cybersecurity risks as part of informed consent form (21 CFR 50.25(a)(2)

and 21 CFR 812.25(g));

• Global, multi-patient and updateability/patchability views (21 CFR 812.25(c), (d));

• Security use case views for functionality with safety risks (e.g., implant programming)

(21 CFR 812.25(c), (d));

• Software Bill of Materials (21 CFR 812.25(c), (d)); and

• General labeling – connectivity and associated general cybersecurity risks,

updateability/process (21 CFR 812.25(f)).

FDA intends to review this information in the context of the overall benefit-risk assessment of

investigational devices as outlined in the guidance “Factors to Consider When Making Benefit-

Risk Determinations for Medical Device Investigational Device Exemptions.”

Therefore,

approval of an IDE based on the documentation recommended above does not preclude the

possibility of future cybersecurity questions or concerns being raised during review of a

subsequent marketing application. This is, in part, due to the understanding that design changes

may be needed and the temporal nature of cybersecurity. Cybersecurity improvements will likely

be needed between the time of clinical trials and when the device is submitted for marketing

authorization (e.g., operating system no longer supported or nearing end of support, third-party

software updates).

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/factors-consider-when-

making-benefit-risk-determinations-medical-device-investigational-device

Contains Nonbinding Recommendations

Appendix 4. General Premarket Submission Documentation

Elements and Scaling with Risk

As stated in Section IV.D. and throughout the guidance, device cybersecurity design and

documentation are expected to scale with the cybersecurity risk of that device. While

documentation breadth is expected to scale, each type of documentation identified throughout the

guidance is recommended for all premarket submissions for devices with potential cybersecurity

risks.

Table 1 below summarizes the specific documentation elements identified throughout the

guidance for premarket submissions, the associated sections of the guidance for the document,

and whether the documentation is recommended for IDE submissions. While documentation

elements are identified for the security risk management report, manufacturers can provide the

documentation elements in a way that is consistent with their existing documentation processes.

This table is not intended to serve as merely a deliverable checklist, as the processes outlined

throughout the guidance are intended to help align generation of these documents and their

resultant content with FDA’s recommendations. This table represents one possible way to

organize the recommended information.

The below documentation will naturally scale with the level of cybersecurity risk. This will be

most evident in the breadth of the Threat Modeling and Architecture Views documentation.

• For example, a device with either only one hardware connection (e.g., USB port) or a

SaMD product with limited other software dependencies and connectivity will likely only

need to have single architecture view for each of the global system, multi-patient harm,

and updateability/patchability views; the security use case view(s) will likely be limited

to a smaller subset of unique views to address the available connectivity and software.

• For a device with greater complexities such as, but not limited to, networking, wireless

connections, cloud, and/or commercial operating systems, multiple architecture views

may be needed for the multi-patient harm and updateability/patchability views as there

may be multiple ways to cause multi-patient harm or update elements of the device.

Additionally, many security use case views will likely be needed to convey the various

unique security and clinical use cases throughout the architecture.

Table 1. Recommended Premarket Submission Documentation

Type of Premarket

Submission

Documentation

Guidance Section(s)

IDE Submission*

Cybersecurity Risk

Management Report

Sections V., VI.B.

Could be helpful to submit, but

not specifically recommended

- Threat Model

(may include

Architecture

Views)

Sections V.A.1., V.A.3.,

V.A.4., V.A.5., V.B.2.,

Appendix 1, Appendix 2

Could be helpful to submit, but

not specifically recommended

(see Architecture View

recommendations)

Contains Nonbinding Recommendations

Type of Premarket

Submission

Documentation

Guidance Section(s)

IDE Submission*

- Cybersecurity

Risk Assessment

Sections V.A.2., V.A.3.,

V.A.4., V.A.5., V.A.6.

Could be helpful to submit, but

not specifically recommended

- SBOM

Sections V.A.4., VI.A.

Recommended

- Vulnerability

Assessment and

Software Support

Section V.A.4.

Could be helpful to submit, but

not specifically recommended

- Unresolved

Anomalies

Assessment

Section V.A.5.

Could be helpful to submit, but

not specifically recommended

- Traceability

Sections V.A., V.A.1.,

V.A.2., V.A.3., V.A.4.,

V.A.5, V.A.6., V.B.1., V.B.2.,

V.C., VI.A.

Could be helpful to submit, but

not specifically recommended

Measures and Metrics

Section V.A.6.

Could be helpful to submit, but

not specifically recommended

Architecture Views

Section V.B.

Recommended

• Global, Multi-patient and

Updateability/Patchability

views

• Security Use Case views

for functionality with

safety risks

- Requirements

Sections V.B.1., Appendix 1

Recommended

• Global, Multi-patient and

Updateability/Patchability

views

• Security Use Case views

for functionality with

safety risks

- Architecture

Views (may be

included in Threat

Model)

Sections V.A.1., V.B.2.,

Appendix 1, Appendix 2

Recommended

• Global, Multi-patient and

Updateability/Patchability

views

• Security Use Case views

for functionality with

safety risks

Testing

Section V.C.

Could be helpful to submit, but

not specifically recommended

Labeling

Section VI.A.

Recommended

• Informed Consent Form

to include cybersecurity

risks

Contains Nonbinding Recommendations

Type of Premarket

Submission

Documentation

Guidance Section(s)

IDE Submission*

• General Cybersecurity

Labeling - Connectivity

and associated general

cybersecurity risks,

updateability/process

Cybersecurity

Management Plans

Section VI.B.

Could be helpful to submit, but

not specifically recommended

*For the purposes of this table, “recommended” refers to the elements of an IDE submission

FDA discusses in Appendix 3 of this document; “could be helpful to submit, but not specifically

recommended” refers to additional elements that could be helpful to FDA if submitted, but are

not specifically recommended in Appendix 3. If a device-specific guidance contains additional or

different recommendations to those in this table, the device-specific recommendations should be

followed. If a manufacturer is unsure, they should utilize the FDA Q-submission process.

Contains Nonbinding Recommendations

Appendix 5. Terminology

The terminology listed here are for the purposes of this guidance and are intended for use in the

context of assessing medical device cybersecurity. These terms are not intended to be applied in

any context beyond this guidance.

Anomaly – any condition that deviates from the expected behavior based on user needs,

requirements, specifications, design documents, or standards.

Asset – anything that has value to an individual or an organization.

Attack Surface Analysis – evaluation of attack surface to determine all avenues of ingress and

egress to and from a system including common vulnerabilities and exposed ports and services.

Authentication – the act of verifying the identity of a user, process, or device as a prerequisite to

allowing access to the device, its data, information, or systems, or provision of assurance that a

claimed characteristic of an entity is correct.

Authenticity – information, hardware, or software having the property of being genuine and

being able to be verified and trusted; confidence that the contents of a message originate from the

expected party and has not been modified during transmission or storage.

Authorization – the right or a permission that is granted to a system entity to access a system

resource.

Availability – the property of data, information, and information systems to be accessible and

usable on a timely basis in the expected manner (i.e., the assurance that information will be

available when needed).

Boundary Analysis – the process of uniquely assigning information resources to an information

system, which defines the security boundary for that system.

Closed Box Testing – a method of software testing that examines the functionality of an

application without peering into its internal structures of workings.

Definition is adapted from ISO/IEC 27032 Information technology — Security techniques — Guidelines for

cybersecurity, clause 4.6.

Definition is adapted from ANSI/ISA 62443-1-1:2018.

Definition is adapted from NIST FIPS 200 Minimum Security Requirements for Federal Information and

Information Systems and from ISO/IEC 18014-2:2009(E) Information technology – Security techniques - Time-

stamping Services - Part 2: Mechanisms producing independent tokens, clause 3.

Definition is adapted from NIST SP 800-53 Security and Privacy Controls for Federal Information Systems and

Organizations.

Definition is adapted from CNSSI 4009-2015 Committee on National Security Systems (CNSS) Glossary.

Definition is adapted from ISO IEC 27000-2018, Clause 3.7 and CNSSI 4009-2015 CNSS Glossary.

Definition is adapted from NIST Special Publication 800-18 Revision 1 Guide for Developing Security

Plans for Federal Information Systems.

Definition is adapted from CNSSI 4009-2015 CNSS Glossary.

Contains Nonbinding Recommendations

Compensating Controls – a safeguard or countermeasure deployed, in lieu of, or in the absence

of controls designed in by a device manufacturer. These controls are external to the device

design, configurable in the field, employed by a user, and provide supplementary or comparable

cyber protection for a medical device.

Confidentiality – the property of data, information, or system structures to be accessible only to

authorized persons and entities and are processed at authorized times and in the authorized

manner, thereby helping ensure data and system security. Confidentiality provides the assurance

that no unauthorized users (i.e., only trusted users) have access to the data, information, or

system structures.

Configuration – the possible conditions, parameters, and specifications with which a device or

system component can be described or arranged.

Configuration Management – a collection of activities focused on establishing and maintaining

the integrity of information technology products and information systems, through control of

processes for initializing, changing, and monitoring the configurations of those products and

systems throughout the system development lifecycle.

Cryptography – the discipline that embodies the principles, means, and methods for providing

information security; including confidentiality, data integrity, non-repudiation, and

authenticity.

Cybersecurity – the process of preventing unauthorized access, modification, misuse or denial

of use, or the unauthorized use of information that is stored, accessed, or transferred from a

medical device to an external recipient.

Decommission – a process in the disposition process that includes proper identification,

authorization for disposition, and sanitization of the equipment, as well as removal of Patient

Health Information (PHI) or software, or both.

Decryption – is the cryptographic transformation of encrypted data (called “ciphertext”) into

non-encrypted form (called “plaintext”).

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Disposal – a process to end the existence of a system asset or system for a specified intended

use, appropriately handle replaced or retired assets, and to properly attend to identified critical

Definition is adapted from NIST Special Publication “Assessing Security and Privacy Controls in Federal

Information Systems and Organizations,” NIST SP 800-53A Rev. 4.

Definition is adapted from ISO IEC 27000-2018, Clause 3.10: Property that information is not made available or

disclosed to unauthorized individuals, entities, or processes.

Definition is adapted from NIST SP 800-128 Guide for Security-Focused Configuration Management of

Information Systems.

Definition is adapted from NIST SP 800-53 Rev. 4.

Definition is adapted from CNSSI 4009-2015 CNSS Glossary.

Definition is adapted from ISO IEC 27032: 2012, Clause 4.20.

Definition is adapted from Medical Device and Health IT Joint Security Plan (JSP).

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Definition is cited from NIST SP 800-82 Guide to Industrial Control Systems (ICS) Security.

Contains Nonbinding Recommendations

disposal needs (e.g., per an agreement, per organizational policy, or for environmental, legal,

safety, security aspects).

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Encryption – is the cryptographic transformation of data (called “plaintext”) into a form (called

“ciphertext”) that conceals the data’s original meaning to prevent it from being known or

used.

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End of support – a point beyond which the product manufacturer ceases to provide support,

which may include cybersecurity support, for a product or service.

Exploitability – the feasibility or ease and technical means by which the vulnerability can be

exploited by a threat.

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Firmware – software program or set of instructions programmed on the flash read-only memory

(ROM) of a hardware device. It provides the necessary instructions for how the device

communicates with the other computer hardware.

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Fuzz Testing – process of creating malformed or unexpected data or call sequences to be

consumed by the entity under test to verify that they are handled appropriately.

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Hardening – a process intended to eliminate a means of attack by patching vulnerabilities and

turning off nonessential services.

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Hardening, when applied to computing, is the practice of

reducing a system's vulnerability by reducing its attack surface. Hardening may involve a

reduction in attack vectors by culling the pathways or vectors attackers would use (e.g., patching

vulnerabilities and turning off nonessential services).

Hardware – the material physical components of an information system.

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Integrity – the property of data, information and software to be accurate and complete and have

not been improperly or maliciously modified.

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Lifecycle – all phases in the life of a medical device, from initial conception to final

decommissioning and disposal.

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Malware – software or firmware intended to perform an unauthorized process that will have

adverse impact on the confidentiality, integrity, or availability of an information system.

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101

Definition is adapted from 6.4.14.1 Disposal process purpose ISO/IEC/IEEE 12207:2017(E).

102

Definition is cited from NIST SP 800-82 Guide to ICS Security.

103

Definition is adapted from the Common Vulnerability Scoring System (CVSS) specification document (v3.1).

104

Definition is adapted from NISTIR 8183. https://nvlpubs.nist.gov/nistpubs/ir/2017/NIST.IR.8183.pdf

105

Definition is cited from ANSI/ISA 62443-1-1:2018.

106

Definition is cited from NIST SP 800-152.

107

Definition is cited from CNSSI 4009-2015 CNSS Glossary.

108

Definition is adapted from AAMI TIR 57 Clause 2.15.

109

Definition is cited from ANSI/AAMI/ISO 14971:2019 Medical devices – Application of risk management to

medical devices.

110

Definition is cited from NIST SP 800-53 Rev. 4.

Contains Nonbinding Recommendations

Patch – a “repair job” for a piece of programming; also known as a “fix”. A patch is the

immediate solution to an identified problem that is provided to users. The patch is not necessarily

the best solution for the problem, and the product developers often find a better solution to

provide when they package the product for its next release. A patch is usually developed and

distributed as a replacement for or an insertion in compiled code (that is, in a binary file or object

module). In many operating systems, a special program is provided to manage and track the

installation of patches.

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Patient harm – injury or damage to the health of patients, including death.

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Programmable logic – hardware that has undefined function at the time of manufacture and

must be programmed with software to function (e.g., Field-programmable gate array).

Reasonably foreseeable misuse – use of a product or system in a way not intended by the

manufacturer, but which can result from readily predictable human behavior.

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Resilience – the ability of an information system to continue to: (i) operate under adverse

conditions or stress, even if in a degraded or debilitated state, while maintaining essential

operational capabilities; and (ii) recover to an effective operational posture in a time frame

consistent with mission needs.

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Secure Product Development Framework (SPDF) – a set of processes that reduce the number

and severity of vulnerabilities in products. Additional information about an SPDF and its

implementation is discussed in Section IV.C. and throughout the guidance.

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Security Architecture – a set of physical and logical security-relevant representations (i.e.,

views) of system architecture that conveys information about how the system is partitioned into

security domains and makes use of security-relevant elements to enforce security policies within

and between security domains based on how data and information must be protected. The

security architecture reflects security domains, the placement of security-relevant elements

within the security domains, the interconnections and trust relationships between the security-

relevant elements, and the behavior and interactions between the security-relevant elements.

116

111

Definition is adapted from NIST SP 800-45 Version 2.

112

Patient harm from cybersecurity risks is discussed at length throughout this guidance and the FDA guidance

“Postmarket Management of Cybersecurity in Medical Devices” available at

https://www.fda.gov/regulatory-

information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices

113

Definition is adapted from ISO 14971:2019.

114

Definition is cited from NISTSP 800-53 Rev. 4 definition of Information System Resilience.

115

The term “Secure Product Development Framework” was developed for the purposes of this guidance to help

reflect and encompass the concepts related to secure development lifecycles and frameworks. While the term SPDF

is new, the concepts around secure product development and risk management are not new, and align with

expectations in the Quality System and Labeling Regulations. As cybersecurity continues to evolve, FDA continues

to align its terminology to reflect best practices.

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Definition is cited from NIST 800-160v1, Systems Security Engineering.

Contains Nonbinding Recommendations

Security Strength – a measure of the computational complexity associated with recovering

certain secret and/or security-critical information concerning a given cryptographic algorithm

from known data (e.g., plaintext/ciphertext pairs for a given encryption algorithm).

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Throughout this guidance “strong” and other iterations of this term may be used that apply to this

definition.

Security Risk Management – a process (or processes) that evaluates and controls threat-based

risks. For security risk management, this includes an evaluation of the impact of exploitation on the

device’s safety and effectiveness, the exploitability, and the severity of patient harm if exploited.

Software Bill of Materials (SBOM) – a formal inventory of software components and

dependencies, information about those components, and their hierarchical relationships.

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The

software components in an SBOM include, but are not limited to, commercial, open source, off-

the-shelf, and custom software components. See Section V.A.2. for a more complete description

of an SBOM.

System – the combination of interacting elements or assets organized to achieve one or

more function.

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Threat – Threat is any circumstance or event with the potential to adversely impact the device,

organizational operations (including mission, functions, image, or reputation), organizational

assets, individuals, or other organizations through an information system via unauthorized

access, destruction, disclosure, modification of information, and/or denial of service. Threats

exercise vulnerabilities, which may impact the safety or effectiveness of the device.

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Threat modeling – a methodology for optimizing system, product, network, application, and

connection security by identifying objectives and vulnerabilities, and then defining

countermeasures to prevent, or mitigate the effects of, threats to the system.

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Trustworthy Device – a medical device that: (1) is reasonably secure from cybersecurity

intrusion and misuse; (2) provides a reasonable level of availability and reliability; (3) is

reasonably suited to performing its intended functions; and (4) adheres to generally accepted

security procedures to support correct operation.

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Uncontrolled risk – when there is unacceptable residual risk of patient harm due to

inadequate compensating controls and risk mitigations.

117

Definition is cited from NIST SP 800-108.

118

Definition is adapted from NTIA’s Framing Software Component Transparency: Establishing a Common

Software Bill of Materials (SBOM), available at

https://www.ntia.gov/files/ntia/publications/

ntia_sbom_framing_2nd_edition_20211021.pdf

119

Definition is adapted from ISO/IEC/IEEE 12207:2017.

120

Definition is adapted from NIST SP 800-53.

121

Definition is adapted from CNSSI 4009-2015 CNSS Glossary.

122

Definition is adapted from NIST SP 800-32 Introduction to Public Key Technology and the Federal PKI

Infrastructure.

Contains Nonbinding Recommendations

Unresolved anomaly – a defect that still resides in the software because a sponsor deemed it

appropriate not to correct or fix the anomaly, according to a risk-based rationale about its impact

to the device’s safety and effectiveness.

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Updatability and Patchability – the ease and timeliness with which a device and related assets

can be changed for any reason (e.g., feature update, security patch, hardware replacement).

Update – corrective, preventative, adaptive, or perfective modifications made to software of a

medical device.

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Vulnerability – a weakness in an information system, system security procedure(s), internal

control(s), human behavior, or implementation that could be exploited.

Vulnerability Chaining – the sequential exploit of multiple vulnerabilities in order to attack to

attack a system, where one or more exploits at the end of the chain require the successful

completion of prior exploits in order to be exploited.

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123

Definition is consistent with the Premarket Software Guidance (available at https://www.fda.gov/regulatory-

information/search-fda-guidance-documents/guidance-content-premarket-submissions-software-contained-medical-

devices) even though we use the terms differently.

124

Definition is cited from IMDRF Guidance “Principles and Practices for Medical Device Cybersecurity” available

at http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-200318-pp-mdc-n60.pdf

125

Definition is adapted from the Common Vulnerability Scoring System (CVSS) specification document (v3.1).