FDA AI/ML SaMD Action Plan
FDA AI/ML SaMD Action Plan — Software as a Medical Device
United States · FDA AI/ML SaMD Action Plan (Jan. 12, 2021)
- Status
- In effect
- Took effect
- January 12, 2021
- Applies to
- Manufacturers of AI/ML SaMD
- Enforced by
- FDA / CDRH
FDA's 5-part roadmap for regulating AI/ML-based Software as a Medical Device, including a proposed Predetermined Change Control Plan framework that lets developers update models without full FDA re-review.
Who is protected: Patients receiving care that involves AI/ML medical devices
Legal detail
FDA AI/ML SaMD Action Plan (Jan. 12, 2021): articulates 5 actions — (1) tailored regulatory framework with PCCP, (2) GMLP, (3) patient-centered transparency, (4) regulatory science methods for bias and robustness, (5) real-world performance monitoring. Foundation for FDA's AI/ML SaMD reviews and the 2024 Transparency Guiding Principles.
Key facts
| Jurisdiction | United States |
|---|---|
| Level | Federal |
| Strength | Moderate |
| Enacted | January 12, 2021 |
| Citation | FDA AI/ML SaMD Action Plan (Jan. 12, 2021) |
| Private right of action | No, agency enforcement only |
| Penalties | FDCA enforcement: warning letters, recalls, civil penalties |
| Topics | healthcare AI · automated decision-making |
| Agency page | FDA AI/ML SaMD Action Plan (PDF) |
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