Staff at the U.S. Food and Drug Administration (FDA) are reportedly struggling to meet application review deadlines for medical device and tobacco products due to recent staff reductions.
According to an article posted on the website of Reuters News Service, the U.S. Department of Government Efficiency (DOGE) fired around 1000 probationary FDA employees in February, most of whom worked in the agency’s centers for tobacco, food, and medical devices. The government has also said that it will reduce the total number of jobs at U.S. health agencies, including 3500 at the FDA.
The recent staff cuts have resulted in a doubling of the number of new product applications assigned to the remaining FDA scientists and staff, according to three scientists who spoke to Reuters on condition of anonymity.
Under federal law, the FDA typically has 180 days to conduct and complete its review of new device applications. The FDA reportedly approved more than 3000 medical devices in 2024, including more than 30 high-risk devices. The recent staff reductions will make it challenging at best for the agency to continue to review device applications at last year’s pace.
The Reuters article about the impact of FDA layoffs is available at https://www.reuters.com/business/healthcare-pharmaceuticals/fda-staff-struggle-meet-product-review-deadlines-after-doge-layoffs-2025-03-27/.
