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  
CyberMed@fda.hhs.gov. 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 ocod@fda.hhs.gov. 
 
 
 
 
 
 
 
 
 
 
 
 
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-Guidance@fda.hhs.gov 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, ocod@fda.hhs.gov, 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.1 For more information 
 
1 Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 
        1  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 Devices2 and Standards Development and the Use of Standards in Regulatory 
Submissions Reviewed in the Center for Biologics Evaluation and Research.3  
 
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, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys 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 function4 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.  
 
 
2 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-
voluntary-consensus-standards-premarket-submissions-medical-devices 
3 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/standards-development-
and-use-standards-regulatory-submissions-reviewed-center-biologics-evaluation 
4 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 FDAs guidance: Content of Premarket Submissions for Device Software Functions, available 
at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-
device-software-functions  
        2  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 product5 (such as drug-device and biologic-device combination products) when the 
device constituent part presents cybersecurity considerations,6 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.7 
 
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 systemssuch as healthcare 
facility networks, other devices, and software update serversto which it is connected. 
 
Events across the healthcare sector have stressed the importance of cybersecurity to patient 
safety. The WannaCry8 ransomware9 affected hospital systems and medical devices across the 
globe. Vulnerabilities identified in commonly used third-party components, like URGENT/1110 
and SweynTooth,11 have led to potential safety concerns across a broad range of devices that are 
 
5 21 CFR 3.2(e). 
6 21 CFR 4.2. 
7 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). 
8 Additional information on the WannaCry Ransomware attack is available at https://h-isac.org/may-16-2017-
wannacry-update/  
9 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 Agencys (CISAs) webpage 
https://www.cisa.gov/stopransomware/ransomware-101  
10 For more information, see FDAs Cybersecurity webpage, available at https://www.fda.gov/medical-
devices/digital-health-center-excellence/cybersecurity   
11 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 
        3  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.12 
 
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,13 
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 FDAs 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).14 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 rulemaking15 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 FDAs 
Postmarket Cybersecurity Guidance, Cybersecurity for Networked Medical Devices Containing 
 
12 Additional information on the German hospital ransomware attack is available at 
https://www.wired.co.uk/article/ransomware-hospital-death-germany  
13 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-
management-cybersecurity-medical-devices  
14 See Appendix 5, Terminology.  
15 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 firms 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. 
        4  Contains Nonbinding Recommendations 
Off-the-Shelf (OTS) Software,16 and Content of Premarket Submissions for Device Software 
Functions,17 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,18 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.19 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 
 
16 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-
networked-medical-devices-containing-shelf-ots-software 
17 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-
premarket-submissions-software-contained-medical-devices 
18 Available at http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-200318-pp-mdc-n60.pdf 
19 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. 
        5  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,20 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.21 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 FDAs guidance titled Content of Premarket Submissions for 
Device Software Functions.22  
 
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 FDAs 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 
 
20 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).  
21 The recommendations in this guidance are not intended to suggest that FDA will evaluate an applicants 
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 devices 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. 
22 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-
premarket-submissions-software-contained-medical-devices 
23 See 21 CFR 820.30. 
        6  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 
products 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 devices 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 devices 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;24  
  The risks presented by cybersecurity vulnerabilities;  
  The exploitability of the vulnerabilities; and  
  The risk of patient harm due to vulnerability exploitation. 
 
 
24 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)).  
        7  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.25 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 
systems 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 devices 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 devices 
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 systems 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 
 
25 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  
        8  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.26 
 
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)).27  
  
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 devices 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 FDAs assessment of a devices safety and effectiveness. 
 
 
26 As previously discussed, section 524B of the FD&C Act requires the submission of certain documentation for 
cyber devices. 
27 For more information regarding the substantial equivalence review standard, please refer to FDAs 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 
        9  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 FDAs 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.28 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.29  
 
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 FDAs 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) 30 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.31 
 
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 
 
28 Addressing cybersecurity risks is in addition to addressing other risks, including software, biocompatibility, 
sterilization, and electromagnetic compatibility, among others. 
29 For more information, please see the NIST Cybersecurity Framework available at 
https://www.nist.gov/cyberframework  
30 Medical Device and Health IT Joint Security Plan (JSP) is available at https://healthsectorcouncil.org/the-joint-
security-plan/ 
31 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. 
       10  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 manufacturers 
entire quality system, addressed throughout the TPLC.32 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 FDAs 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.33 FDA recommends that security risk 
management processes, as detailed in the QS regulation,34 be established or incorporated into 
those that already exist, and should address the manufacturers 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.  
 
32 The TPLC processes include design and development, manufacturing, postmarket monitoring, delivering device 
software and firmware updates, and servicing, among others.  
33 AAMI TIR57 Principles for medical device securityRisk 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.  
34 21 CFR 820. 
       11  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 transfer35 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 TIR57.36 Manufacturers should include their security risk management 
reportsincluding the outputs of their security risk management processesin 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.37 In the subsections below, we discuss FDAs 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 manufacturers 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.  
 
 
35 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 
36 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 securityRisk management. 
37 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. 
       12  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.38 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.  
 
 
38 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 
       13  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 FDAs 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)39 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 Catalog40 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.  
 
39 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/ 
40 Available at https://www.cisa.gov/known-exploited-vulnerabilities-catalog 
       14  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,41 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 FDAs guidance Multiple Function Device 
Products: Policy and Considerations;42 
  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 Devices43 
and Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software, 
medical devices commonly include third-party software components,44 including off-the-shelf 
 
41 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-considerations-
and-pre-market-submission-recommendations-interoperable-medical-devices 
42 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/multiple-function-
device-products-policy-and-considerations 
43 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-
medical-devices  
44 The use of component in this guidance is consistent with the definition in 21 CFR 820.3. 
       15  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 manufacturers 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 devices 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.45 This may be accomplished 
through different methods, such as source code escrow or source code backups, among others.46  
 
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. 
 
 
 
45 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. 
46 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. 
       16  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 products life.47  
 
Because vulnerability management is a critical part of a devices security risk management 
processes, an SBOM or an equivalent capability should be maintained as part of the devices 
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 FDAs 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 
FDAs guidance documents Off-The-Shelf (OTS) Software Use in Medical Devices48 and 
Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software49 
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).50 
 
In addition to the minimum elements identified by NTIA, for each software component 
contained within the SBOM, manufacturers should include in the premarket submission: 
 
47 For additional information, see the Department of Commerce National Telecommunications and Information 
Administrations multi-stakeholder process for software transparency, available at 
https://www.ntia.doc.gov/SoftwareTransparency 
48 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/shelf-software-use-
medical-devices 
49 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-
networked-medical-devices-containing-shelf-ots-software 
50 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. 
       17  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 components 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 CISAs Known Exploited Vulnerabilities Catalog.51 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  
FDAs 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 anomalys impact on 
the devices safety and effectiveness, and consult the Premarket Software Guidance to assess the 
associated documentation recommended for inclusion in such devices 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.52  
 
51 Available at https://www.cisa.gov/known-exploited-vulnerabilities-catalog 
52 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/  
       18  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 
anomalys impact continuously, which could significantly impact the acceptability of the risk 
when compared to an anomaly assessment that didnt 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 devices 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 manufacturers processes, FDA recommends that a 
manufacturer track and record the measures and metrics below,53 and provide them in premarket 
submissions and PMA annual reports (21 CFR 814.84), when available.54 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: 
 
 
53 The measures and metrics provided are examples; alternative or additional measures and metrics may also be 
considered and reported.  
54 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. 
       19  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 FDAs 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 process55 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. 
 
55 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  
       20  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.56 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.57 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.  
 
 
56 Views are discussed in more detail in the following subsections and Appendix 2. 
57 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/  
       21  Contains Nonbinding Recommendations 
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 systemwhich include management, technical, and 
operational controlsthere 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 devices 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 
       22  Contains Nonbinding Recommendations 
cybersecurity risk management throughout the device lifecycle with the agency.58 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,59 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.60 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 
 
58 For more information, see FDAs 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 
59 See 21 CFR 820.30.  
60 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 
       23  Contains Nonbinding Recommendations 
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 
       24  Contains Nonbinding Recommendations 
patients through security risk. This may change the devices 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. 
 
(c)  Updatability and Patchability View 
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 
       25  Contains Nonbinding Recommendations 
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 evidence61 of the following testing and 
analyses: 
  Abuse or misuse cases, malformed and unexpected inputs; 
  Robustness. 
  Fuzz testing. 
 
61 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. 
       26  Contains Nonbinding Recommendations 
  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. 
 
       27  Contains Nonbinding Recommendations 
There are numerous authoritative resources for outlining security testing that may partially fulfill 
the testing outlined above.62  
 
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)63 to ensure that the type of user has the capability to take appropriate actions to manage 
those risks.  
 
 
62 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. 
63 See FDAs 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 
       28  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., operators 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.64 
 
The following are examples of information that may be included in labeling to communicate 
relevant security information to users:65 
 
  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 devices 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, 
 
64 For more information regarding FDAs 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/ 
65 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. 
       29  Contains Nonbinding Recommendations 
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)66 and Customer Security Documentation as outlined in the Medical Device and Health 
IT Joint Security Plan (JSP)67 may address a number of the above recommendations. 
B.  Cybersecurity Management Plans 
Recognizing that cybersecurity risks evolve as technology evolves throughout a devices 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 
 
66 The Manufacturer Disclosure Statement for Medical Device Security is available at 
https://www.nema.org/standards/view/manufacturer-disclosure-statement-for-medical-device-security 
67 Available at https://healthsectorcouncil.org/the-joint-security-plan/ 
       30  Contains Nonbinding Recommendations 
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;68 
  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 
FDAs Postmarket Cybersecurity Guidance. 
 
 
 
 
68 Available at https://www.cisa.gov/known-exploited-vulnerabilities-catalog 
       31  Contains Nonbinding Recommendations 
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 controlsinformation and entitiesand a 
properly-secured system is able to prove the existence of both.  
 
Authentication of information69 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 manufacturers threat 
model and/or risk analyses reveal the need for it.  
 
On a technical level, the strength of a devices 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.  
 
69 For the purposes of this control, information includes the software/firmware itself, as well as input and output 
data. 
       32  Contains Nonbinding Recommendations 
 
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 strong70 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); 
 
70 See the definition of security strength in Appendix 5, Terminology. 
       33  Contains Nonbinding Recommendations 
  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 privileges71 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 
intent72 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: 
 
 
71 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. 
72 For the purposes of this guidance, signal of intent is specific to the implementation of NFC communications. 
       34  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 140-3,73 NIST 
Suite B74), 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. 
 
73 NIST FIPS 140-3 Cryptographic Module Validation Program available at 
https://csrc.nist.gov/Projects/cryptographic-module-validation-program/fips-140-2 
74 NIST FIPS 140-2 Suite B available at https://csrc.nist.gov/CSRC/media/projects/cryptographic-module-
validation-program/documents/security-policies/140sp2851.pdf 
       35  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),75 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-listing76 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. 
 
75 For more information regarding UDI, see FDAs webpage https://www.fda.gov/medical-devices/unique-device-
identification-system-udi-system/udi-rule-guidances-training-and-other-resources 
76 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 
       36  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 confidentiality77 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 
 
77 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 
       37  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.78 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. 
 
78 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.  
 
       38  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 
readable79 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,80 excessive bandwidth usage by other products, disrupted 
quality of service (QoS),81 and/or excessive jitter82 (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 products lifecycle. Despite best efforts, undiscovered, exploitable 
vulnerabilities may exist in devices after they are marketed. This is especially true over the 
 
79 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 
80 Denial of Service is an attack that prevents or impairs the authorized use of the information system, resources, or 
services. 
81 From CNSSI 4009 Committee on National Security Systems (CNSS) Glossary.  
82 From NIST Computer Security Resource Center Glossary available at https://csrc.nist.gov/glossary/term/jitter   
       39  Contains Nonbinding Recommendations 
devices 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. 
   
       40  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);  
       41  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;  
       42  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. 
   
 
83 For the purposes of this guidance, identity management means the process that governs the authentication and 
authorization of users to devices and assets. 
       43  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.84 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).  
   
 
84 Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/factors-consider-when-
making-benefit-risk-determinations-medical-device-investigational-device 
       44  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 FDAs 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  Guidance Section(s)  IDE Submission* 
Submission 
Documentation 
Cybersecurity Risk  Sections V., VI.B.  Could be helpful to submit, but 
Management Report  not specifically recommended 
-  Threat Model  Sections V.A.1., V.A.3.,  Could be helpful to submit, but 
(may include  V.A.4., V.A.5., V.B.2.,  not specifically recommended 
Architecture  Appendix 1, Appendix 2  (see Architecture View 
Views)  recommendations) 
       45  Contains Nonbinding Recommendations 
Type of Premarket  Guidance Section(s)  IDE Submission* 
Submission 
Documentation 
-  Cybersecurity  Sections V.A.2., V.A.3.,  Could be helpful to submit, but 
Risk Assessment  V.A.4., V.A.5., V.A.6.  not specifically recommended 
-  SBOM  Sections V.A.4., VI.A.  Recommended 
-  Vulnerability  Section V.A.4.  Could be helpful to submit, but 
Assessment and  not specifically recommended 
Software Support 
-  Unresolved  Section V.A.5.  Could be helpful to submit, but 
Anomalies  not specifically recommended 
Assessment 
-  Traceability  Sections V.A., V.A.1.,  Could be helpful to submit, but 
V.A.2., V.A.3., V.A.4.,  not specifically recommended 
V.A.5, V.A.6., V.B.1., V.B.2., 
V.C., VI.A. 
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  Sections V.A.1., V.B.2.,  Recommended  
Views (may be  Appendix 1, Appendix 2    Global, Multi-patient and 
included in Threat  Updateability/Patchability 
Model)  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 
       46  Contains Nonbinding Recommendations 
Type of Premarket  Guidance Section(s)  IDE Submission* 
Submission 
Documentation 
  General Cybersecurity 
Labeling - Connectivity 
and associated general 
cybersecurity risks, 
updateability/process 
Cybersecurity  Section VI.B.  Could be helpful to submit, but 
Management Plans   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.   
       47  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.85 
 
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.86 
 
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.87 
 
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.88  
 
Authorization  the right or a permission that is granted to a system entity to access a system 
resource.89 
 
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).90  
 
Boundary Analysis  the process of uniquely assigning information resources to an information 
system, which defines the security boundary for that system.91 
 
Closed Box Testing  a method of software testing that examines the functionality of an 
application without peering into its internal structures of workings.92 
 
 
85 Definition is adapted from ISO/IEC 27032 Information technology  Security techniques  Guidelines for 
cybersecurity, clause 4.6. 
86 Definition is adapted from ANSI/ISA 62443-1-1:2018. 
87 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. 
88 Definition is adapted from NIST SP 800-53 Security and Privacy Controls for Federal Information Systems and 
Organizations. 
89 Definition is adapted from CNSSI 4009-2015 Committee on National Security Systems (CNSS) Glossary. 
90
 Definition is adapted from ISO IEC 27000-2018, Clause 3.7 and CNSSI 4009-2015 CNSS Glossary. 
91 Definition is adapted from NIST Special Publication 800-18 Revision 1 Guide for Developing Security  
Plans for Federal Information Systems. 
92 Definition is adapted from CNSSI 4009-2015 CNSS Glossary. 
       48  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.93 
 
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.94 
 
Configuration  the possible conditions, parameters, and specifications with which a device or 
system component can be described or arranged.95  
 
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.96 
 
Cryptography  the discipline that embodies the principles, means, and methods for providing 
information security; including confidentiality, data integrity, non-repudiation, and 
authenticity.97 
 
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.98 
 
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.99 
 
Decryption  is the cryptographic transformation of encrypted data (called ciphertext) into 
non-encrypted form (called plaintext).100 
 
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 
 
93 Definition is adapted from NIST Special Publication Assessing Security and Privacy Controls in Federal 
Information Systems and Organizations, NIST SP 800-53A Rev. 4. 
94 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. 
95 Definition is adapted from NIST SP 800-128 Guide for Security-Focused Configuration Management of 
Information Systems. 
96 Definition is adapted from NIST SP 800-53 Rev. 4. 
97 Definition is adapted from CNSSI 4009-2015 CNSS Glossary. 
98 Definition is adapted from ISO IEC 27032: 2012, Clause 4.20. 
99 Definition is adapted from Medical Device and Health IT Joint Security Plan (JSP). 
100 Definition is cited from NIST SP 800-82 Guide to Industrial Control Systems (ICS) Security. 
       49  Contains Nonbinding Recommendations 
disposal needs (e.g., per an agreement, per organizational policy, or for environmental, legal, 
safety, security aspects).101  
 
Encryption  is the cryptographic transformation of data (called plaintext) into a form (called 
ciphertext) that conceals the datas original meaning to prevent it from being known or 
used.102  
 
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.103 
 
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.104 
 
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.105 
 
Hardening  a process intended to eliminate a means of attack by patching vulnerabilities and 
turning off nonessential services.106 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.107 
 
Integrity  the property of data, information and software to be accurate and complete and have 
not been improperly or maliciously modified.108 
 
Lifecycle  all phases in the life of a medical device, from initial conception to final 
decommissioning and disposal.109  
 
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.110 
 
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. 
       50  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.111 
 
Patient harm  injury or damage to the health of patients, including death.112   
 
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.113 
 
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.114 
 
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.115 
   
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. 
116 Definition is cited from NIST 800-160v1, Systems Security Engineering.  
       51  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).117 
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 
devices 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.118 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.119 
 
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.120   
 
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.121   
 
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.122  
 
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 NTIAs 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. 
       52  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 devices safety and effectiveness.123  
 
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.124 
 
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.125 
 
 
 
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). 
       53