FDA Cybersecurity Guidance §V.A.4, VII.C.3, Appendix 4

FDA Cybersecurity Guidance: §V.A.4 Third-Party Software Components, §VII.C.3 Software Bill of Materials (SBOM) (Section 524B(b)(3)), §Appendix 4 General Premarket Submission Documentation Elements and Scaling with Risk

Pre-QMSR Part 820: §820.184 Device history record.

IEC 62304: §8.1.2 Identify soup

An SBOM that is created for submission and then not maintained is an accurate snapshot of the software composition at a single point in time that becomes progressively less accurate with every subsequent change — and an inaccurate SBOM feeds incorrect component data into vulnerability monitoring tools, producing false-negative alerts that allow newly applicable vulnerabilities to go undetected. An SBOM entry without a component unique identifier (such as a PURL or CPE) is harder to match programmatically against vulnerability data. Update triggers such as a new release, a component change or discovery of a critical vulnerability reflect the principle that SBOM accuracy is not a function of calendar time but of events that change the software composition or the relevance of its contents; a weekly-regenerated SBOM with no change is no more accurate than the prior version, while a missed component upgrade is an immediate accuracy gap regardless of when the last scheduled regeneration occurred. SBOM distribution and access procedures matter because the SBOM's value extends beyond internal use: customers and connected healthcare networks need visibility into device software composition to apply their own network security controls.

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.