FDA Section 524B requires a documented vulnerability disclosure process. Fill in the blanks; get a publish-ready policy aligned to ISO/IEC 29147 and CISA's CVD guidance.
Reviewed by
Christian Espinosa
Founder & CEO, Blue Goat Cyber
What you'll see after you submit
Common misconceptions
Myth: A security@ inbox is enough to satisfy FDA's CVD requirement.
Reality: §524B requires a documented process: intake, triage SLAs, coordination with reporters, and a public-facing policy. An inbox without a policy is a deficiency.
Myth: We can wait until a researcher reports something to publish a policy.
Reality: FDA explicitly looks for the published CVD policy in the premarket submission. No policy → an AI letter on day 60.
Myth: Bug bounty = CVD program.
Reality: Bounties pay for findings; CVD governs how findings are handled, disclosed, and reported to FDA. You can have CVD without a bounty, but not the other way around.
Myth: Safe-harbor language is boilerplate.
Reality: It's the single most-cited reason researchers will or won't report. Generic legalese chills disclosure; ISO 29147-aligned safe-harbor language unlocks it.
References & further reading
Tracked signals that change what reviewers expect. Items move on as new ones land.
RHEL 7 Extended Life Support phase ends - devices on RHEL 7 need a compensating-controls memo
AI-letter analysis - 62% of FDA cyber deficiencies cite a missing or stale CVD URL
CISA Secure by Design pledge expanded with VEX publication expectation
AAMI TIR97:2019 errata published - clarifies postmarket triage SLAs
Run a real CVD program with triage, remediation SLAs, and FDA reporting.
Read Postmarket cybersecurity servicesOur own CVD policy and security contact.
Read Coordinated Vulnerability Disclosure pageComplete §524B premarket package including CVD evidence.
Read FDA premarket cybersecurityPCCP, threat model starter, SBOM readiness.
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