FDA sets new record for novel device green lights in CDRH annual report

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, according to the agency, and includes 29 devices that had previously received boosts from the FDA’s breakthrough label.

Among the FDA’s selected examples of notable innovative devices were Masimo’s wearable alarm for detecting potential opioid overdoses; a nerve-stimulating implant from Inspire Medical Systems for obstructive sleep apnea; the relaunch of Owlet’s baby-monitoring smart sock; and the Snoo motorized bassinet to keep infants sleeping on their backs.

At the same time, CDRH was able to flip 21 products that had received EUAs during the pandemic to full, traditional regulatory green lights. The FDA had published its transition plan offering guidance for COVID tests and related devices making the switch in March 2023, as the U.S. government began to officially step away from its public health emergency posture that May.

“FY2023 saw the highest volume of MDUFA premarket submissions in at least a decade,” the report said, referring to the agency’s user fee-funded review programs for medical devices. “However, even in the presence of this increased workload, CDRH is on track to meet its FY2023 review goals.”

In terms of staffing, CDRH said it was able to fill 100% of the open reviewer positions listed for the 2023 fiscal year—for a total center headcount of 2,230—and that it is currently on track to meet fiscal 2024’s hiring goals.