FDA Reverses Course on Device Center Staff Cuts, Rehires Majority of Dismissed Employees

The Food and Drug Administration (FDA) has quickly backtracked on its decision to terminate numerous employees from its Center for Devices and Radiological Health (CDRH), rescinding termination letters and inviting many staff members to return to their positions. This sudden reversal comes just days after a controversial wave of layoffs that raised concerns about potential delays in medical device approvals and the United States' position as a leader in medical technology.

Widespread Reinstatements Across CDRH Divisions

According to multiple sources, including industry group AdvaMed and anonymous FDA employees, a significant number of CDRH staff who were dismissed last week have been asked to return to their roles. The reinstatements appear to span various divisions within the center, including teams working on diabetes devices, artificial intelligence, neurological devices, cardiovascular devices, and anesthesiology and respiratory devices.

Scott Whitaker, CEO of AdvaMed, stated, "Coming out of the weekend, it appears a sizable number of expert reviewers will return to FDA. This would be welcome news, and I appreciate the administration for acting quickly." Whitaker emphasized the shared goal of maintaining an efficient and effective FDA review process to advance critical medical technologies.

Impact on Device Review Process and Timeline Uncertainties

While the reinstatement of key personnel is a positive development for the medical device industry, questions remain about the potential impact on ongoing device reviews. Some employees had already turned in their laptops and badges, raising concerns about possible delays in application processing.

The initial layoffs had prompted warnings from AdvaMed about potential delays or suspensions of medical device applications. As staff return to their positions, it remains unclear how quickly normal operations can resume and whether timelines for affected applications will be adjusted.

Scope of Layoffs and Rehiring Efforts

Reports suggest that the Trump administration had initially fired over 1,000 FDA employees during the Presidents Day weekend. While the exact number of rehires is not confirmed, sources indicate that the FDA plans to bring back around 300 people in total.

The rehiring efforts appear to be broad in scope, including staff involved in reviewing high-profile projects such as Elon Musk's Neuralink, as well as employees working in surgical and infection control devices, digital health, and cardiovascular devices.

Steven Grossman, a regulatory consultant with HPS Group, noted that the initial layoffs seemed to target probationary employees, either those in their first few years of government service or recently promoted through competitive recruitment. Grossman criticized the process as "arbitrary," stating, "It is good that some are being called back, but that doesn't undo the harm of lay-off done by fiat rather than performance reviews."

As the FDA works to reintegrate dismissed staff, the medical device industry and patients alike will be watching closely to see how quickly the CDRH can return to full operational capacity and address any backlog created by this brief but significant disruption.