Shuren: CDRH Needs More Funding For Active Surveillance, Supply Chain Monitoring

 
• By Elizabeth Orr
  
Generate a summary of this article
Listen to this article
Beta

In a Tuesday webinar from the Alliance for a Stronger FDA, CDRH head Jeffrey Shuren said that a “politicized and toxic” environment in Washington could limit the agency’s ability to keep up with innovation and responding to new threats.

Jeff Shuren is the Director of the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration
Jeff Shuren, seen during a recent Alliance for a Stronger FDA webinar. • Source: Webinar Screengrab

The number of innovative devices receiving premarket authorization from the US Food and Drug Administration has quintupled in the last 15 years, going from 25 in 2009 to 125 in 2023. That’s an improvement device center director Jeff Shuren is rightfully proud of – just as he touts the 4,000 presubmission meetings that the agency held last year, and the dozen new or modified devices that get authorized each day.

But now, the director of the FDA’s Center for Devices and Radiological Health is raising concerns that budget constraints and...

Medtech Insight Podcast

Keep up with the top medtech business and regulatory news.

Medtech Insight brings you interviews and analysis, on the go.

SpotifyApple PodcastsWebsite

More from Regulation

More from Policy & Regulation