FDA asks industry input on competency-based rules for generative AI medical devices

The FDA announced it is soliciting comments on a proposed competency-based framework for overseeing medical devices that incorporate generative artificial intelligence.

The agency says the approach would focus on the capabilities of the device and the developers’ processes rather than prescribing specific technical solutions.

In the same announcement, the FDA also released final guidance on therapeutic equivalence evaluations for abbreviated new drug applications, outlining how TE codes will be assigned in the Orange Book.

The guidance clarifies the criteria for bioequivalence determinations and is intended to provide clearer expectations for manufacturers seeking approval.