AMA weighs in on FDA’s regulatory proposal for GenAI-based medtech

The AMA advises that regulatory speed should not compromise safety, and that physicians should shape evaluation criteria and clinical performance standards. The AMA advises that regulatory speed should not compromise safety, and that physicians should shape evaluation criteria and clinical performance standards. The FDA’s request for stakeholder feedback around its GenAI-based medtech proposal ended on 19 October. Credit: Tada Images / Shutterstock.com The American Medical Association (AMA) has responded to the US Food and Drug Administration’s (FDA) call for feedback on its proposed regulatory approach to generative artificial intelligence (GenAI)-based medical devices, asserting that oversight should incorporate a “least-burdensome, risk-based…

Source: Medical Device Network