Dive Brief:
- The Food and Drug Administration authorized 124 new medical devices last year, setting a record in the process.
- Excluding emergency use authorizations (EUAs), the level of activity was higher than at any point in the more than 40-year history of the FDA’s Center for Devices and Radiological Health (CDRH).
- The FDA shared the figures in the CDRH’s annual report, which also features updates on its work on MDUFA V goals and details of an uptick in breakthrough designations after the slump in 2022.
Dive Insight:
The number of new devices authorized annually by the FDA has increased over the past 15 years. In 2009 and 2010, the FDA authorized 25 and 29 novel medical devices, respectively. Since then, the figure has never dropped below 51. Before the pandemic, annual authorizations peaked at 106 in 2018.
EUAs contributed to a record of 132 authorizations in 2020, including the first point-of-care and home-use tests for COVID-19. The number of authorizations slipped to 103 and 84 over the next two years. In 2022, the FDA said it managed to authorize 84 novel devices despite the “heavy workload” of COVID-19 and mpox.
With those demands easing, the number of authorizations rebounded last year. The FDA highlighted the first over-the-counter test for the preliminary detection of fentanyl in urine, which the agency cleared in 16 days, and Owlet’s medical pulse oximeter for infants as examples of new devices that received marketing authorizations in 2023.
The FDA received 19,100 submissions last year, an increase from 18,800 in 2022. It also awarded 167 breakthrough designations, up from 135 in 2022.
The agency also had more staff to do the work. The number of “dedicated CDRHers” increased from 2,011 to 2,230 as the FDA filled all of the 141 positions for its 2023 financial year specified by the Medical Device User Fee Amendments (MDUFA V). The FDA said it is on track to meet its hiring goal for the current financial year.
That expanded team met another of the FDA’s MDUFA V goals. The FDA said it “exceeded by 20% our pre-submission goal of providing written feedback to an applicant within 70 calendar days or five days prior to a meeting 75% of the time.”
