ARTICLE SUMMARY:
Mass firings hit the FDA's device center on February 15. Excerpted from Pathways’ Pick of the Week February 19: CDRH Staff Slashed, Signs of Medicare Rulemaking, China Approval Trends, and More.
CDRH staff slashed. Reviewers and scientists across FDA’s device center were fired February 15, raising questions throughout industry about the current capacity to perform premarket reviews, meet user fee performance commitments, and carry out other activities. Among the terminated staff was Ross “Rusty” Segan, who joined CDRH last fall to run its Office of Product Evaluation and Quality (OPEQ), which houses all of the center’s premarket review staff, as well as surveillance and compliance officers. The actions came as part of the Trump administration’s mass terminations of “probationary” employees carried out at federal agencies over the President’s Day weekend.
The total number of CDRH employees who received termination notices this weekend is not yet clear, but, according to multiple sources speaking on background, it may be above 200, which would account for about 10% of the center’s employees. Many of the impacted individuals were hired in the past year or two, but there are also more experienced scientists who originally joined FDA under a fellowship and entered a new probationary period after officially transitioning to a civil service position. Industry sources with close ties to the agency suggested departments focused on medical imaging, diagnostics, artificial intelligence, cybersecurity, and diabetes devices were among the most impacted.