FDA Regulation of AI

FDA Regulation of Artificial Intelligence (AI) and Machine Learning in Software as a Medical Device

On April 2, 2019, the FDA published a discussion paper “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Discussion Paper and Request for Feedback” that describes the FDA’s foundation for a potential approach to premarket review for artificial intelligence and machine learning-driven software modifications.  One can submit comments on the discussion paper by June 3, 2019.
FDA’s current software framework would be likely to require premarket submissions for most changes to AI based devices. In the new framework, the FDA introduces a “predetermined change control plan” in premarket submissions.  This plan would include the types of anticipated modifications—referred to as the “Software as a Medical Device Pre-Specifications”—and the associated methodology being used to implement those changes in a controlled manner that manages risks to patients —referred to as the “Algorithm Change Protocol.”
In this approach, the FDA would expect a commitment from manufacturers on transparency and real-world performance monitoring for artificial intelligence and machine learning-based software as a medical device, as well as periodic updates to the FDA on what changes were implemented as part of the approved pre-specifications and the algorithm change protocol.

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