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Shuren Expects Longer CDRH Review Times

 
• By Elizabeth Orr

The FDA staff cuts will probably mean longer device review times at least in the short term, speakers said at a recent webinar. But innovations like AI and third-party review could offer some hope, even as tariffs create a new set of problems.

Speakers during a 3 April webinar on the future of the FDA, clockwise from top left: Martin Leon, Jeff Shuren, Juan Granada, Kenneth OUriel and Adam Saltman.
Screenshot of speakers during a 3 April webinar on the future of the FDA, clockwise from top left: Martin Leon, Jeff Shuren, Juan Granada, Adam Saltman and Kenneth Ouriel. (Citeline)

Recent staff cuts at the US Food and Drug Administration are likely to lead to longer product review times, former device center director Jeff Shuren said in a recent webinar in which he and other medtech leaders laid out their expectations for device regulation in the near future.

Medical device contract research firm North American Science Associates (NAMSA) hosted the 3 April webinar, which also featured Columbia University cardiology professor Martin Leon; NAMSA executive VP Kenneth Ouriel; and Juan Granada, president and CEO of the

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More from Medtech Insight

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States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.