FDA PCCP Guidance (AI/ML devices)
FDA Final Guidance — Predetermined Change Control Plans for AI/ML-Enabled Device Software Functions
United States · FDA Guidance (Dec. 4, 2024); 21 U.S.C. § 360e-4
- Status
- In effect
- Took effect
- December 4, 2024
- Applies to
- Sponsors of AI/ML-enabled medical device software functions submitted for FDA marketing authorization
- Enforced by
- FDA Center for Devices and Radiological Health
FDA finalized a framework that lets manufacturers update an AI-enabled medical device after clearance without filing a new submission for each change — but only if they pre-specify what changes are allowed, how they'll be validated, and how transparency to clinicians and patients will be preserved.
Who is protected: Patients using AI/ML-enabled medical devices that may update after FDA clearance
Legal detail
Final guidance (Dec. 4, 2024) implementing § 3308 of the Food and Drug Omnibus Reform Act of 2022 (21 U.S.C. § 360e-4). Establishes that a marketing submission for an AI/ML-enabled device software function may include a Predetermined Change Control Plan describing modifications, the Modification Protocol, and an Impact Assessment so that pre-specified changes do not trigger a new 510(k)/De Novo/PMA.
Key facts
| Jurisdiction | United States |
|---|---|
| Level | Federal |
| Strength | Moderate |
| Enacted | December 4, 2024 |
| Citation | FDA Guidance (Dec. 4, 2024); 21 U.S.C. § 360e-4 |
| Private right of action | No, agency enforcement only |
| Penalties | Failure to follow the PCCP triggers full new-submission requirement; misbranding/adulteration enforcement |
| Topics | healthcare AI · automated decision-making · AI disclosure and transparency |
| Agency page | Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices — Final Guidance |
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