Efforts by the U.S. Food and Drug Administration (FDA) to oversee the recall of faulty medical devices are being directly impacted by insufficient staffing at the agency.
This news comes straight from the U.S. Government Accountability Office (GAO). According to a report issued by the agency in early December, the FDA failed to meet its 3-month target for terminating manufacturer-initiated device recalls during the five-year period from fiscal years 2020 through 2024, with nearly 74% of recalls exceeding the 3-month termination goal.
The reason for the FDA’s oversight failure? According to the GAO report, “Insufficient staff limit FDA’s ability to conduct oversight activities.” The potential consequences? Insufficient staffing “can create inefficiencies in the process and potentially put lives at risk.”
According to an article posted to the MedTechDive website, the GAO’s report on oversight of medical device recalls was initiated by a Congressional request in late 2023. Further, the timeframe detailed in the GAO report occurred before the U.S. Department of Health and Human Services (HHS) initiated significant staff reductions in February and April 2025, which included personnel working to support the inspection of medical devices, drugs, and vaccines.
The GAO report includes several recommendations to address the staffing gap on medical device oversight, including strategic increases in staffing and revising regulations to require device manufacturers to implement FDA recommendations for manufacturer-initiated recalls.
The U.S. GAO report on staffing impacts on medical device recalls is available at https://www.gao.gov/products/gao-26-107619.
The MedTechDive article is available at https://www.medtechdive.com/news/fda-needs-staff-device-recalls-gao/807900/.