Fierce Biotech January 22, 2024
In what the FDA described as a “transformative year” for its Center for Devices and Radiological Health, the agency set a new record in issuing green lights to innovative medical devices and diagnostic tests, topping its history spanning more than four decades.
“We officially turned a corner on the COVID-19 pandemic and moved toward a more sustainable workload, including prioritizing normal review timelines for all incoming premarket submissions,” wrote CDRH Director Jeff Shuren in the agency’s annual report (PDF).
While receiving more than 19,000 product submissions during 2023, CDRH granted marketing nods to 124 novel devices—covering premarket approvals and de novo clearances, but not counting COVID-era Emergency Use Authorizations. That amounts to a five-fold increase since 2009’s total of 25,...
Today's Sponsors
Today's Sponsor