FDA medical device cybersecurity updates
US Food and Drug Administration
FDA cybersecurity updates that affect medical device 510(k), De Novo, and PMA submissions - guidance changes, eSTAR updates, QMSR alignment, and postmarket expectations.
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Mar 18, 2026·Enforcement signalActiveMedium impact
FDA postmarket cybersecurity 'update letter' cadence increases
Blue Goat Cyber tracking shows a year-over-year jump in postmarket cybersecurity update letters citing missing CVD URLs, stale SBOMs, and lack of triage SLAs.
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Feb 3, 2026·Final GuidanceActiveHigh impact
FDA finalizes 2026 premarket cybersecurity guidance
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.
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Feb 3, 2026·Guidance supersededWithdrawnMedium impact
FDA 2023 premarket cybersecurity guidance superseded
The September 2023 premarket cybersecurity guidance is superseded by the February 3, 2026 final guidance.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.
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Feb 2, 2026·Final RuleActiveHigh impact
FDA Quality Management System Regulation (QMSR) takes effect
The 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.
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Dec 4, 2024·Final GuidanceActiveHigh impact
FDA finalizes Predetermined Change Control Plans (PCCP) guidance
Final 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.
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Mar 29, 2023·StatuteActiveHigh impact
FD&C Act Section 524B - cyber device requirements in effect
Section 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.
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