For cyber devices on covered submission pathways, Section 524B requires a plan including coordinated vulnerability disclosure. Generate a draft for manufacturer and legal review.
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: For covered cyber-device submissions, the statutory plan includes coordinated vulnerability disclosure and related procedures. An inbox alone does not document intake, assessment, coordination, remediation, and communication. No fixed acknowledgement or triage SLA is universally prescribed.
Myth: We can wait until a researcher reports something to publish a policy.
Reality: Provide applicable CVD plan evidence and the information requested by the FDA. This tool cannot predict whether or when the FDA will issue a deficiency.
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: Safe harbor is a substantive legal commitment. Have counsel approve its scope, terms, and authority before offering 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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