‘Banner Year’ For FDA’s Device Center Includes Record Number Of Novel Authorizations

A new annual report argues that last year was both transformative and historic for the US FDA’s Center for Devices and Radiological Health. The center authorized the highest number of novel medical devices in history while turning the corner on the pandemic.

Medical Breakthrough Ahead
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The Center for Devices and Radiological Health authorized more medical devices in 2023 than at any other time in its 40-year history — excluding emergency use authorizations — and transitioned from its pandemic footing to a more sustainable workload, according to CDRH’s annual report.

“In fact, this was a banner year for the center,” said device centers director Jeff Shuren in the report’s message, which cited the first over-the-counter fentanyl test — Alltest Fentanyl Urine Test

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