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.
