FDA Reverses Course on CDRH Staff Cuts, Bringing Back Dismissed Employees

In a sudden turn of events, the Food and Drug Administration (FDA) has rescinded termination letters for many employees at its Center for Devices and Radiological Health (CDRH) who were dismissed last week. This development comes after widespread criticism from industry leaders and concerns about potential delays in medical device reviews.

Reinstatement of CDRH Staff

Over the weekend, numerous CDRH employees received calls inviting them to return to their positions. The FDA has confirmed the reinstatement by restoring IT and security access for these employees, who returned to work on Monday. According to an industry source familiar with the matter, "most, if not all of the CDRH people are being asked back."

The rehired staff span various critical areas 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

Scott Whitaker, CEO of AdvaMed, a medical device industry group, 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."

Impact on Medical Device Reviews and Industry Concerns

The initial staff cuts at CDRH raised significant concerns about potential delays in medical device application reviews. AdvaMed had reported hearing from individuals who received notices that their applications might be delayed or suspended due to the staffing changes.

While the reinstatement of staff is a positive development, it remains unclear how the timeline for affected applications will change. Some employees had already turned in their laptops and badges, which may cause additional delays in resuming normal operations.

Steven Grossman, a regulatory consultant with HPS Group, noted that the initial 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."

The FDA's swift reversal highlights the critical role that CDRH staff play in maintaining the United States' position as a leader in medical device innovation and ensuring patient safety. As the situation continues to unfold, industry stakeholders and patients alike will be closely monitoring the impact on device reviews and approvals in the coming weeks and months.