Over the weekend, the Food and Drug Administration reversed course on many of the terminations it had issued to staff members at its medical device division, according to information from industry group Advamed and FDA employees who requested anonymity.
Multiple employees at the Center for Devices and Radiological Health (CDRH) confirmed they received communications during the weekend requesting their return to work. The FDA subsequently restored their IT and security access, enabling them to resume their duties on Monday.
According to an industry insider familiar with the situation, the vast majority, if not all, of the CDRH personnel who were dismissed are now being invited to return. The reinstatements span various departments, including teams working on diabetes devices, artificial intelligence technologies, and devices related to neurology, cardiovascular medicine, and anesthesiology and respiratory care.
Advamed CEO Scott Whitaker expressed approval of the administration’s swift action to reverse the dismissals. “The return of these expert reviewers to the FDA is positive news,” Whitaker stated via email. He emphasized the shared objective of maintaining an efficient FDA review process that supports the advancement of critical medical technologies for American patients.
The initial terminations had raised serious concerns within the industry. Advamed had received reports of potential delays or suspensions in medical device application reviews, with Whitaker warning about possible impacts on U.S. leadership in medical device innovation and patient safety. Initial estimates suggested between 230 and 240 CDRH staff members had been affected by the cuts.
Reuters reported that approximately 300 FDA employees in total would be rehired, citing sources with indirect knowledge. The original dismissals, which occurred over Presidents Day weekend under the Trump administration, had affected more than 1,000 FDA employees. Among those being brought back are staff members involved in reviewing Elon Musk’s Neuralink project.
Additional reinstatements included personnel working in surgical and infection control devices, digital health, and cardiovascular devices, according to Stat’s reporting based on anonymous sources.
HPS Group regulatory consultant Steven Grossman noted that the initial dismissals appeared to target probationary employees, including those in their first years of government service or recently promoted through competitive recruitment. “While the reinstatements are positive, they don’t fully address the damage caused by arbitrary layoffs that weren’t based on performance evaluations,” Grossman commented via email.
The impact on application timelines remains uncertain, even as staff return to their positions. The processing of some applications may still face delays, as many employees had already surrendered their equipment and credentials during the brief period of termination.
The reinstatements represent a significant shift from the widespread FDA dismissals that occurred during the holiday weekend. The return of these specialized staff members is particularly crucial for
maintaining the agency’s ability to review and approve new medical devices, ensuring continued innovation in the healthcare sector and protecting patient safety.
The episode has highlighted the complex nature of federal workforce management and the potential consequences of broad personnel decisions on critical regulatory functions. While the quick reversal has helped maintain continuity in the FDA’s device review operations, questions remain about the long-term implications of such administrative actions on agency morale and efficiency.