The rehiring effort, also reported by the New York Times, Associated Press and other media outlets, follows a series of mass terminations initiated by President Donald Trump’s administration, which led to the dismissal of probationary employees across the FDA. According to Reuters, more than 1,000 FDA employees were dismissed.
The layoffs affected various departments, including the Center for Devices and Radiological Health (CDRH). This follows reports that officials expected the U.S. Dept. of Health and Human Services (HHS) to fire 5,200 probationary employees overall after the confirmation of Robert F. Kennedy Jr. as HHS secretary.
Citing a person familiar with the conversations, the New York Times said today that nearly all of the roughly 180 medical division employees who had been let go would get to return to work.
The layoffs have raised concerns in the medical device industry about potential delays in product approvals. Scott Whitaker, CEO of medtech trade group AdvaMed, said the firings could disrupt the FDA’s review process. “Bringing these experts back would help ensure an efficient regulatory system that supports medical innovation,” Whitaker said.
Some eliminated positions were funded by industry-paid user fees, raising questions about the motivations behind the cuts. The White House has previously said the reductions were intended to improve government efficiency and reduce spending.
The NY Times said AdvaMed lobbied the administration in a letter and in meetings to get the laid off medtech regulators reinstated.
While some former FDA employees have accepted offers to return, others remain hesitant. Reuters reported that several scientists who were let go had previously received strong performance reviews, yet their termination letters cited inadequate performance. MassDevice also highlighted concerns from engineers, scientists and communications specialists at the FDA.
The long-term effects of the staffing reductions and rehiring efforts remain uncertain. Industry stakeholders continue to monitor how the changes may impact regulatory timelines for medical devices and other healthcare innovations.
[Related: Trump is back: Here’s what his initial actions mean for medtech]
The Neuralink connection
Neuralink, which is developing brain-computer interfaces, faced regulatory hurdles in 2023 when the FDA initially rejected its request to begin clinical trials due to safety concerns. The agency later approved the trials that are currently underway.
It remains unclear whether dismissed Neuralink reviewers have been asked to return. The company has not commented on the FDA staffing changes.
Reuters reported that last week’s firings included around 20 people in the FDA’s Office of Neurological and Physical Medicine Devices. Several of those employees worked on Neuralink and other BCI devices, the report said, citing two sources with knowledge of the matter.
Reuters said sources did not believe the Trump administration — and Musk as head of the Dept. of Government Efficiency (DOGE) — specifically targeted them due to their work on Neuralink’s regulatory submissions. The report, however, quoted former FDA official, Victor Krauthamer, expressing concern over the impact the cuts could have.
