Novel Device Approval Numbers Drop Sharply, But All is Well, FDA's Shuren Says

ARTICLE SUMMARY:

The FDA review program and US medtech innovation ecosystem remain strong, despite a sharp drop in the number of novel devices approved by FDA in 2019, says Jeff Shuren, the agency’s device director. A look at the FDA trend numbers crunched by Market Pathways, and our discussion with Shuren about the state of the review program and what to expect in 2020.

After four record-setting years, the number of novel devices approved by FDA fell by more than 30% in 2019. But, in an interview, FDA device center director Jeff Shuren, MD, says the decline does not signal a problem with the agency’s review process or the US medtech pipeline.

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