FDA Cybersecurity Guidance §V.A.6, VI.B, VII.E

FDA Cybersecurity Guidance: §V.A.6 TPLC Security Risk Management, §VI.B Cybersecurity Management Plans, §VII.E Reasonable Assurance of Cybersecurity of Cyber Devices

ISO 13485: §7.3.9 Control of design and development changes

Pre-QMSR Part 820: §820.30(b) Design and development planning.

IEC 81001-5-1: §5.8.7 SECURE decommissioning guidelines for HEALTH SOFTWARE, §6 SOFTWARE MAINTENANCE PROCESS

A medical device without a defined security support window creates an open-ended patching obligation the manufacturer has not resourced and the customer cannot plan around — and the patient who continues using the device long after security support has effectively ended does so without being informed that newly discovered vulnerabilities will no longer receive remediation. FDA guidance VI.A lists, among information that may be included in labeling, end-of-support and end-of-life information, and says that 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." FDA guidance V.A.6 recommends that manufacturers "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", and 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)."

The FDA's September 2023 final guidance replaced the October 2014 final guidance 'Content of Premarket Submissions for Management of Cybersecurity in Medical Devices'. The guidance is headed 'Contains Nonbinding Recommendations' and states that, in general, FDA guidance documents 'do not establish legally enforceable responsibilities' and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited; it recommends how to meet the requirements of Section 524B of the FD&C Act (added by FDORA, enacted December 29, 2022), which became effective March 29, 2023. FDA's cybersecurity Refuse to Accept (RTA) policy for cyber devices, issued March 29, 2023, expired on October 1, 2023; from that date FDA expects sponsors of cyber devices to have had sufficient time to prepare premarket submissions that contain the information Section 524B requires (FDA CDRH webinar, November 2, 2023).

Section 524B created new statutory requirements for 'cyber devices' — any device that includes software validated, installed, or authorized by the sponsor as a device or in a device, has the ability to connect to the internet, and contains any such technological characteristics validated, installed, or authorized by the sponsor that could be vulnerable to cybersecurity threats. Under Section 524B(b), the sponsor must (1) submit 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; (2) design, develop, and maintain processes and procedures to provide a reasonable assurance that the device and related systems are cybersecure, and make available postmarket updates and patches on a reasonably justified regular cycle for known unacceptable vulnerabilities and as soon as possible out of cycle for critical vulnerabilities that could cause uncontrolled risks; (3) 'provide to the Secretary a software bill of materials, including commercial, open-source, and off-the-shelf software components'; and (4) comply with such other requirements as the Secretary may require through regulation to demonstrate reasonable assurance that the device and related systems are cybersecure.

The statute says nothing about SBOM format, depth or end-of-support dates. Those come from the guidance (Section V.A.4), which recommends that manufacturers provide machine-readable SBOMs consistent with the NTIA minimum elements and, for each software component, the 'software level of support' and the end-of-support date, and says 'Industry-accepted formats of SBOMs are encouraged.' The guidance names no format; SPDX and CycloneDX are formats used in practice, not named by the statute or by the guidance. The guidance describes a robust SBOM as including 'the upstream software dependencies' of proprietary, purchased/licensed, and open-source software (V.A.4(a)), and recommends that an SBOM or an equivalent capability be maintained as part of configuration management and regularly updated to reflect changes to the software in marketed devices. Section V.C lists 'Software composition analysis of binary executable files' among the testing and analyses for which it recommends providing details and evidence.