What Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan requires
This action plan outlines the FDA's multi-pronged approach to regulating AI/ML-based Software as a Medical Device (SaMD), focusing on a total product lifecycle framework that includes a Predetermined Change Control Plan (PCCP) for managing algorithm modifications. It applies to all manufacturers developing and marketing AI/ML-based SaMD in the United States.
Pillar: Medical & Healthcare · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device
SHA-256 integrity: d1f856506c8b3b5c0ba138632345d584c6a1c737e3d89b7a6075135f496eb2ed
Primary Citations — 7 traced to source
- AI/ML-Based SaMD Action Plan, January 2021, Action 1: Further develop the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan.
- AI/ML-Based SaMD Action Plan, January 2021, Action 2: Encourage harmonization of Good Machine Learning Practice (GMLP) development.
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