FDA official urges regulatory flexibility for post-market surveillance of AI

A Food and Drug Administration official told Inside TeleHealth that proposed change control plans for emerging health technologies -- like artificial intelligence and machine-learning software -- are not enough to ensure adequate post-market surveillance, Inside TeleHealth reported Feb. 22.

The agency is seeking feedback from manufacturers at the development stage on how to implement necessary guardrails while also promoting innovation.

FDA’s draft guidance, “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software...