ARTICLE SUMMARY:
Companies need to be mindful of the challenges FDA device reviewers are facing in the wake of staff cuts and ongoing instability. In this edition of Consultants Corner, former center reviewers offer advice on how companies currently pursuing premarket authorization should approach a beleaguered FDA.
It’s not business as usual at CDRH. For the past two months, the Trump administration, in particular the Department of Government Efficiency (DOGE), has aggressively acted to reshape and reduce resources at agencies across the federal government, and FDA’s device center has certainly felt the impact.
CDRH was hit particularly hard February 15, when upwards of 200 scientists and other staff designated as “probationary” received termination notices. (See “Trump Firings Impact Device Reviews As Industry Underscores Patient Risk and Fee Commitments,” Market Pathways, February 20, 2025.)
A week later, after significant pushback from industry and others, the administration rescinded many of those notices. It remains unclear exactly how many probationary CDRH staffers were initially laid off, how many were called back, and what proportion of those accepted the reinstatement. The return-to-work rate, however, is less than 100%, including the loss of some scientists with significant expertise, in particular in digital health and AI, according to multiple sources.
Other employees have left in response to buyout incentive offers, while pressures are building from return-to-office orders that started to take effect March 17 and the prospect of future cuts. Meanwhile, those who returned to FDA or remained have faced significant work disruptions.
Device companies pursuing premarket authorization at FDA shouldn’t ignore these ongoing challenges faced by CDRH staff. Several former FDA reviewers from the consultancy MCRA underscored this message during a call organized by the company March 17 to discuss the impact of recent FDA cuts and potential future actions on the device industry. Here are five considerations from the experts about how companies might make the best of the challenging situation.
