The Food and Drug Administration has begun reinstating numerous employees at its medical device division who were terminated during a mass layoff over Presidents Day weekend, according to industry group Advamed and several FDA staff members who requested anonymity.
Multiple employees at the Center for Devices and Radiological Health (CDRH) confirmed they received communications over the weekend reversing their termination notices and restoring their security clearances and IT access. The affected staff returned to work on Monday.
According to an industry insider familiar with the situation, the FDA is seeking to bring back the majority, if not all, of the CDRH personnel who were dismissed. The reinstatements span various departments, including teams working on diabetes devices, artificial intelligence technologies, neurological equipment, cardiovascular devices, and anesthesiology and respiratory products.
Advamed CEO Scott Whitaker expressed relief at the developments, noting that a considerable number of expert reviewers would be returning to their positions. He emphasized the importance of maintaining an efficient FDA review process to advance crucial medical technologies that American patients rely on.
The reversals come after Advamed had raised concerns about potential delays in medical device application reviews, with initial reports suggesting between 230 and 240 CDRH employees had been affected by the cuts. The organization had warned that the dismissals could compromise America’s leadership in medical device innovation and potentially impact patient safety.
Reuters reported that approximately 300 FDA employees in total were slated for rehiring, citing sources with indirect knowledge. The initial layoffs, which occurred under the Trump administration, had affected over 1,000 FDA employees. Among those being reinstated are staff members who had been involved in reviewing Elon Musk’s Neuralink project.
Additional departments seeing reinstatements include surgical and infection control devices, digital health, and cardiovascular devices, according to reporting by Stat based on anonymous sources.
Despite the reinstatements, questions remain about potential delays in application reviews, as many employees had already surrendered their equipment and credentials during the brief period of termination.
Regulatory consultant Steven Grossman of HPS Group noted that the initial cuts appeared to target probationary employees, particularly those in their first few years of government service or recently promoted through competitive recruitment. He criticized the arbitrary nature of the layoffs, suggesting that while the reinstatements were positive, they couldn’t fully mitigate the damage caused by
implementing cuts without proper performance evaluations.
The FDA’s decision to reverse course on these terminations reflects growing concern about maintaining the agency’s ability to effectively review and approve medical devices. The medical device industry had immediately voiced opposition to the cuts, citing potential
disruptions to the review process for new technologies and their impact on patient care.
The reinstatements represent a significant pivot from the agency’s initial actions, though the full impact of the brief disruption on ongoing device reviews and approvals remains to be assessed. Industry observers continue to monitor the situation closely, particularly regarding any lasting effects on review timelines and the agency’s overall operational capacity.
This episode highlights the delicate balance between administrative decisions and the maintenance of critical regulatory functions, especially in an agency responsible for overseeing products that directly affect public health and safety. The swift reversal suggests recognition of the essential role these staff members play in the FDA’s mission to ensure the safety and effectiveness of medical devices in the United States.