FDA Regulation
FDA medical device cybersecurity timeline, 2014 to 2026
Every FDA cybersecurity guidance and Section 524B milestone from 2014 to 2026, with premarket guidance, postmarket guidance, and the law shown as separate tracks.
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Premarket guidance
What the FDA expects in a premarket submission for a device with cybersecurity risk.
- October 2014
- First final premarket cybersecurity guidance.
- September 27, 2023
- Final guidance replaces the 2014 version.
- June 27, 2025
- Updated final premarket guidance.
- February 3, 2026
- Current final premarket guidance.
Postmarket guidance
- December 28, 2016
- Final postmarket cybersecurity guidance. It is still the FDA's dedicated postmarket document.
Law and enforcement
- December 29, 2022
- Section 524B of the FD&C Act enacted in the Consolidated Appropriations Act, 2023.
- March 29, 2023
- Section 524B takes effect for cyber device submissions.
- October 1, 2023
- The FDA begins refuse-to-accept decisions on Section 524B grounds.
Dates from FDA guidance documents and the Consolidated Appropriations Act, 2023.
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