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Medical Devices / Regulatory Affairs

AI Developer Comments on FDA’s Approach for AI/ML-Based SaMD

June 12, 2019
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In a comment to the FDA on how the agency should regulate modifications to software as a medical device (SaMD) that use artificial intelligence (AI) and machine learning (ML),  PathAI said it is “essential that the regulatory framework will allow for iterative improvements of AI/ML, without needing to submit applications to FDA for every device change.”

A developer of AI technology for pathology laboratories, PathAI said it “believes that a major potential benefit of incorporating continuous learning algorithms into devices is clinical improvements and these improvements can lead to improved safety and/or effectiveness; the need to submit applications to FDA for every device change can impede these critical improvements.”

The FDA’s proposed regulatory framework suggests that any modification resulting in a new intended use will require a premarket review.

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