FDA AI/ML SaMD Action Plan — Software as a Medical Device
United States · FDA AI/ML SaMD Action Plan (Jan. 12, 2021)
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.
Technical 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.
Who is protected: Patients receiving care that involves AI/ML medical devices
Who must comply: Manufacturers of AI/ML SaMD
Key facts
| Jurisdiction | United States |
|---|---|
| Level | Federal |
| Status | In effect |
| Protection strength | Moderate protection |
| Effective date | 2021-01-12 |
| Enacted | 2021-01-12 |
| Citation | FDA AI/ML SaMD Action Plan (Jan. 12, 2021) |
| Enforced by | FDA / CDRH |
| Private right of action | No — agency enforcement only |
| Penalties | FDCA enforcement: warning letters, recalls, civil penalties |
| Topics | healthcare AI · automated decision-making |
| Last verified | 2026-06-16 |
| Official source | FDA AI/ML SaMD Action Plan (PDF) ↗ |
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