SOUP Identification and Management

ISO 13485: §7.4.1 Purchasing process

Pre-QMSR Part 820: §820.50 Purchasing controls.

IEC 62304: §5.3.3 Specify functional and performance requirements of soup item, §5.3.4 Specify system hardware and software required by soup item, §8.1.2 Identify soup

Software that is not enumerated cannot be evaluated — and in the medical device context, a third-party library whose functional requirements are undocumented cannot be verified or validated as performing its intended role in the device software correctly or safely. IEC 62304 section 8.1.2 establishes the SOUP identification obligation (title, manufacturer, unique SOUP designator) and sections 5.3.3 and 5.3.4 establish the specification obligation (functional and performance requirements, and the system hardware and software the SOUP item needs) because the alternative — treating all incorporated third-party software as a black box with unspecified requirements — severs the traceability chain from safety-critical functions to the components implementing them. When a safety-relevant function depends on a specific SOUP item's behavior, the absence of documented functional requirements means no defined basis exists for evaluating whether that SOUP item is acceptable for its role or whether a new version remains acceptable after an update. The transitive-dependency requirement reflects the structural reality that a directly-used library that itself depends on a poorly-maintained library carries security and quality risk through that indirect chain — limiting SOUP documentation to direct dependencies provides a false picture of the software composition, as demonstrated repeatedly by supply-chain incidents where compromised transitive dependencies were invisible to component owners.

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.