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

The Food and Drug Administration (FDA) has rescinded termination letters for many employees at its Center for Devices and Radiological Health (CDRH) who were dismissed last week, according to industry sources and FDA staff. This sudden reversal comes after widespread criticism of the cuts, which were part of a larger wave of firings across the agency.

Widespread Reinstatements Across CDRH Divisions

Multiple CDRH employees, speaking on condition of anonymity, confirmed they received calls over the weekend asking them to return to work. These reinstatements span various departments within the center, including:

• Diabetes devices
• Artificial intelligence (AI) devices
• Neurological devices
• Cardiovascular devices
• Anesthesiology and respiratory devices
• Surgical and infection control devices
• Digital health

An industry source familiar with the matter stated that "most, if not all of the CDRH people are being asked back." This widespread recall of staff suggests a significant policy reversal by the FDA leadership.

Impact on Device Reviews and Industry Concerns

Scott Whitaker, CEO of medical device industry group AdvaMed, welcomed the news, stating, "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 had previously voiced concerns about the cuts, warning that they could lead to delays or suspensions in medical device application reviews. He also cautioned that the firings could jeopardize the United States' position as a leader in medical technology and potentially put patients at risk.

While the reinstatement of staff is seen as a positive development, questions remain about the immediate impact on device review timelines. Some employees had already turned in their laptops and badges, which may cause short-term disruptions as they transition back into their roles.

Broader Context of FDA Staffing Changes

The reversal at CDRH is part of a larger story involving FDA staffing. According to Reuters, the Trump administration had fired more than 1,000 FDA employees over the Presidents Day weekend. The agency is now reportedly planning to rehire around 300 people in total, including staff who reviewed Elon Musk's Neuralink project.

Steven Grossman, a regulatory consultant with HPS Group, noted that the initial wave of job cuts 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, stating, "Beyond that, the process seems like it was arbitrary. 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 healthcare community will be closely watching for any lingering effects on the agency's review processes and overall efficiency in bringing new medical technologies to market.