FDA medical device product recalls dropped last year to the lowest number since 2013, according to a Medical Design & Outsourcing analysis of newly released recall data from the regulatory agency.
Device products recalled in fiscal year 2021 (ended Sept. 30) totaled 2,607, a 14.3% drop from the 3,042 recalls reported in fiscal 2020.
The drop in device recalls occurred at the same time the FDA put more emphasis on fighting the COVID-19 pandemic and improving device safety protocols, according to FDA’s Center for Devices and Radiological Health (CDRH) annual report. CDRH Director Dr. Jeff Shuren said in September that the agency was “starting to turn the corner” on catching up on submissions, after having focused on the pandemic and issuing emergency use authorizations (EUA) in record times. But that was also before the virus’s omicron variant hit.
The 2,607 figure from last year is the fewest product recalls dating back to fiscal 2013, when 2,304 devices were recalled. Fiscal 2013 was the first full year for which the FDA made these tallies public.
The agency reported its highest number of recalls, at 3,285, in fiscal 2018. But recalls dropped by 13.5% to 2,843 the following year.
In fiscal 2021, Class I recalls dipped 1.2% to 169, Class II recalls decreased 15% to 2,389 and Class III recalls dropped 19.7% to 49.
The largest year-over-year change of any year and any class since FDA started reporting these numbers was in fiscal 2019 — the last full year before the COVID-19 pandemic — when Class I recalls soared 216.24%. That year, there were 370 Class I recalls, 2,376 Class II recalls (down 23.5%) and 97 Class III recalls (up 43%).
The FDA regulates over 190,000 different devices manufactured by more than 18,000 firms across the world. Since the beginning of the pandemic, the FDA’s CDRH remained heavily focused on the response to the virus and has granted EUA or full marketing authorization for more than 2,000 medical devices that are specifically designed for COVID-19 treatment, detection and diagnosis, according to CDRH’s annual report (PDF download).
Despite the uncertainties of the pandemic, the FDA launched a new program in 2021 to foster innovation to develop safer medical devices, known as the Safer Technologies Program (STeP). The Center for Devices and Radiological Health (CDRH) laid out its efforts to promote safety in its Medical Device Safety Action Plan.
The main strategies of the action plan included establishing a robust medical device patient safety net in the U.S., exploring regulatory options to streamline and modernize timely implementation of postmarket mitigation, spurring innovation toward safer medical devices, advancing medical device cybersecurity and integrating the CDRH’s premarket and postmarket offices and activities to advance the use of a total product life cycle (TPLC) approach to device safety.
