Gen AI policy is a White House priority, CDRH digital health leader says - MedTech Dive

Rick Abramson, director of the FDA's Digital Health Center of Excellence, said draft guidance on generative artificial intelligence should be expected in the coming months, MedTech Dive reported. Abramson made the comments at AdvaMed's The MedTech Conference on Tuesday. The headline on the MedTech Dive article states that generative AI policy is a White House priority, attributing that characterization to the CDRH digital health leader.

The comment period for an FDA discussion paper on regulatory approaches to generative AI closed on Monday, according to the report. The discussion paper places a greater emphasis on postmarket monitoring, the article states. Postmarket monitoring refers to oversight of a product after it has reached the market, rather than only at the point of review before clearance or approval. Abramson's remarks came one day after the comment window closed.

The reported draft guidance would follow the discussion paper and the comment period that ended Monday. Both the discussion paper and the anticipated draft guidance concern regulatory approaches to generative AI, the article states. The article does not state a more specific date for the draft guidance than the coming months, and it does not describe the contents of the comments the FDA received. MedTech Dive's account is based on Abramson's remarks at the AdvaMed conference on Tuesday.