US Food and Drug Administration
Every FDA cybersecurity guidance, rule and draft that affects medical device 510(k), De Novo, and PMA submissions, with a short summary of each and what manufacturers should do.
FDA's 2026 final guidance replaces the 2023 document and sets binding expectations for SBOM, VEX, threat modeling, security testing, postmarket plans, and CVD for every cyber device submission.
Read detailsThe September 2023 premarket cybersecurity guidance is superseded by the February 3, 2026 final guidance. Citing the 2023 document in new submissions is now a stale reference.
Read detailsThe QMSR formally aligns 21 CFR Part 820 with ISO 13485:2016. Cybersecurity design controls, risk management, and supplier controls must now be documented under the harmonized framework.
Read detailsThis draft covers lifecycle management and what to include in marketing submissions for AI-enabled device software, including a section on cybersecurity risks specific to AI, such as tampered training data and attacks on model inputs.
Read detailsFinal PCCP guidance lets manufacturers pre-authorize specified modifications to AI/ML-enabled device software functions without a new submission, provided cybersecurity impacts are scoped up front.
Read detailsIn March 2024 the FDA published a draft explaining how it reads Section 524B, including what counts as a cyber device. That content has since been brought into the final premarket cybersecurity guidance.
Read detailsThis guidance sets out the software documentation the FDA expects in a premarket submission, using two levels (Basic and Enhanced) based on risk. It sits alongside the cybersecurity guidance, which covers the security content.
Read detailsSection 524B (Omnibus 2023) made cybersecurity submission content mandatory for cyber devices. The FDA has issued Refuse to Accept decisions for non-compliant submissions since October 2023.
Read detailsWhen Section 524B took effect, the FDA said it would not refuse submissions for missing 524B content until October 1, 2023, and would work with sponsors during review instead. After that date, submissions missing the required cybersecurity content could be refused.
Read detailsThe FDA's postmarket guidance describes how manufacturers should monitor, assess and fix cybersecurity vulnerabilities in devices already on the market, including when a fix needs to be reported to the FDA and when it does not.
Read detailsThe FDA's 2014 guidance was the agency's first statement of what cybersecurity content belongs in a premarket submission: a hazard analysis, a list of controls, and a plan for updates. Later premarket guidance replaced it.
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