Paste the cybersecurity section of an FDA deficiency letter (AI request, hold letter, or RTA). We categorize each ask and outline a structured response with required evidence.
Reviewed by
Christian Espinosa
Founder & CEO, Blue Goat Cyber
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What you'll see after you submit
Common misconceptions
Myth: An AI letter is just a request for more information.
Reality: AI (Additional Information) letters pause the review clock and require a response within 180 days, or the submission is withdrawn. Treat them as hard deadlines.
Myth: We can answer cybersecurity asks with a narrative.
Reality: Reviewers want artifacts - SBOM files, threat model documents, pen test reports, VEX statements. Narratives without traceable evidence become a second AI letter.
Myth: Each ask should be answered separately and shipped as it's ready.
Reality: FDA expects one consolidated response that addresses every ask. Partial responses restart confusion and extend the clock.
Myth: If we disagree with a deficiency, we should push back.
Reality: Disagreement is fine, but it must be written as a rationale with cited guidance - not as a refusal. Reviewers respond to evidence, not pushback.
References & further reading
Tracked signals that change what reviewers expect. Items move on as new ones land.
FDA cybersecurity Q-Submission Q&A series - May 2026 session
ANSI/AAMI SW96 Amendment 1 draft circulated for member review
AI-letter analysis - 62% of FDA cyber deficiencies cite a missing or stale CVD URL
FDA finalizes 'Cybersecurity in Medical Devices: QMS Considerations and Content of Premarket Submissions'
Turn AI requests and hold letters into accepted responses in days, not months.
Read Deficiency response servicesReal letters with annotated responses.
Read Deficiency letter examplesField-tested checklist for cyber deficiency responses.
Read Response checklistPCCP, threat model starter, SBOM readiness.
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