FDA medical device cybersecurity timeline
| Date | Milestone | Summary | Source |
|---|---|---|---|
| FDA Safety Communication on Medical Device Cybersecurity | First broad FDA warning on medical device cybersecurity risk; called on manufacturers and HDOs to take action. | FDA Safety Communication | |
| Premarket Cybersecurity Guidance (final) | First final FDA guidance establishing cybersecurity expectations in premarket submissions; introduced threat-modeling and risk-management language. | FDA 2014 premarket guidance | |
| Postmarket Cybersecurity Guidance (final) | Defined the postmarket cybersecurity lifecycle, CVD program expectations, and the difference between routine and uncontrolled-risk vulnerabilities. | FDA postmarket guidance | |
| Premarket Cybersecurity Guidance (draft, 2018) | Draft introducing 'Tier 1' and 'Tier 2' devices and the concept of a Cybersecurity Bill of Materials (CBOM). | FDA 2018 draft guidance | |
| Section 524B added to the FD&C Act | Consolidated Appropriations Act, 2023 (Section 3305) added Section 524B, giving FDA explicit statutory authority over cybersecurity in premarket submissions. | Public Law 117-328 | |
| Section 524B effective date | Section 524B took effect and FDA refuse-to-accept authority attached for cyber devices. FDA held off issuing RTAs based solely on 524B until active enforcement began on October 1, 2023. | FDA Refuse-To-Accept policy update | |
| Premarket Cybersecurity Guidance (final, 2023) | First final guidance under Section 524B; established the Secure Product Development Framework (SPDF) and the seven-section cybersecurity content set. | FDA 2023 final guidance | |
| eSTAR mandatory for 510(k) | FDA-CDRH made eSTAR mandatory for 510(k) submissions, including a structured cybersecurity section. | eSTAR program | |
| Premarket Cybersecurity Guidance (final, 2025) | Final guidance superseding the September 2023 final; refined SPDF, threat-modeling and SBOM expectations ahead of the February 2026 update. | FDA 2025 final guidance | |
| eSTAR mandatory for De Novo | eSTAR became the required submission format for De Novo classification requests, with the same cybersecurity section as 510(k). | eSTAR program | |
| Premarket Cybersecurity Guidance (final, 2026) effective | Updated final guidance superseding the June 2025 final, which had superseded the September 2023 final; clarifies SPDF expectations, threat-modeling depth, SBOM contents, and labeling. | FDA 2026 final guidance |
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