IEC 81001-5-1 §9 problem resolution process and complaint handling practices — CVD channels external reporters into the existing vulnerability investigation workflow.
§524B(b)(1) of the FD&C Act requires submitting a postmarket vulnerability plan that includes coordinated vulnerability disclosure and related procedures; FDA guidance (VI.B, VII.C.1) recommends the plan describe the manufacturer's coordinated vulnerability disclosure process.
CVD intake channel monitored with triage procedure and named roles.
Maps to
FDA Cybersecurity Guidance: §VI.B Cybersecurity Management Plans, §VII.C.1 Plans and Procedures (Section 524B(b)(1))
Pre-QMSR Part 820: §820.198 Complaint files.
IEC 81001-5-1: §9 Software problem resolution PROCESS
Requirement text
Per §524B(b)(1) of the FD&C Act, the sponsor of an application or submission described in section 524B(a) of the FD&C Act for a cyber device must submit to the Secretary a plan to monitor, identify, and address, as appropriate, in a reasonable time, postmarket cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure (CVD) and related procedures. FDA's Premarket Cybersecurity Guidance recommends that the cybersecurity management plan include a "Description of their coordinated vulnerability disclosure process" (section VI.B).
Why this clause exists
Security researchers who discover vulnerabilities in medical devices face a structurally adversarial situation when manufacturers have no published disclosure channel: reporting through general complaint processes signals nothing about how the report will be handled, researchers have no assurance they will receive acknowledgment or a remediation timeline, and the absence of a safe harbor statement creates genuine legal uncertainty about whether good-faith research will be met with litigation rather than collaboration. The predictable result — researchers either silently shelving findings or publicly disclosing without coordination — is worse for patient safety than a formal CVD program would produce. Section 524B(b)(1) of the FD&C Act itself requires the postmarket vulnerability plan submitted to FDA to include coordinated vulnerability disclosure and related procedures; the FDA guidance (VI.B, VII.C.1) recommends that the plan describe the manufacturer's coordinated vulnerability disclosure process. Without structured disclosure channels, vulnerabilities known to security researchers may not reach device manufacturers in time for remediation.
What changed
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.
Common gaps (what we see in audits)
- CVD policy written for the submission without working intake channels or triage procedures — A coordinated vulnerability disclosure process needs working intake channels and internal triage procedures, not only a policy document written for the submission.