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Five highlights from FDA’s new AI device regulation Action Plan

On January 12, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) Digital Health Center of Excellence released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan,” which describes the agency’s efforts to regulate products that incorporate AI. It is a direct response to stakeholder feedback to the April 2019 discussion paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device.” Although the Action Plan is light on details for AI regulation, it pledges specific actions that show FDA is moving forward with its “Predetermined Change Control Plan” regulatory framework for machine learning devices. The docket for comments on the plan remains open, and device manufacturers may be interested in providing feedback to FDA on its AI policy proposals, before the agency finalizes its regulatory framework.

1. Tailored regulatory framework for AI/ML-based SaMD – Draft guidance to come

2. Good Machine Learning Process (GMLP)

3. Patient-centered approach incorporating transparency to users – Public workshop to come

4. Regulatory science methods related to algorithm bias & robustness

5. Real-world performance (RWP) – Pilot program to come

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