Many people who were fired from the Food and Drug Administration’s medical device center last week had their termination letters rescinded over the weekend, according to Advamed and three FDA employees who spoke on condition of anonymity.
The three people working at the Center for Devices and Radiological Health said they received calls over the weekend asking them to come back. They received follow-up emails from the FDA confirming their IT and security access had been restored. The employees returned Monday.
An industry source with knowledge of the matter said “most, if not all of the CDRH people are being asked back.”
One of the CDRH employees said people on their team who work on diabetes devices were reinstated, while another said some people working on AI devices came back. The third employee said people working on neurological, cardiovascular, and anesthesiology and respiratory devices were invited back.
“Coming out of the weekend, it appears a sizable number of expert reviewers will return to FDA,” Scott Whitaker, CEO of medical device industry group Advamed, said in an emailed statement. “This would be welcome news, and I appreciate the administration for acting quickly. We all share the same goal—an efficient, effective FDA review process that helps advance the medical technologies American patients depend on. Bringing these specific experts back would help fulfill that mission.”
Whitaker spoke out against the cuts last week, saying Advamed had already heard from people who had received notice that the applications for medical devices may be delayed or suspended. Whitaker said the firings could affect the U.S.’ position as a medtech leader and put patients at risk. At the time, he heard between 230 and 240 were cut from CDRH.
It’s unclear if the timeline for applications affected by the recent terminations will change, even as staff return, as some had already turned in their laptops and badges.
Reuters reported Saturday that the FDA planned to rehire around 300 people in total, citing sources with secondhand knowledge. The Trump administration fired more than 1,000 FDA employees over Presidents Day weekend, according to Reuters. The people who were rehired include staff who reviewed Elon Musk’s Neuralink, according to the report.
People were also reinstated who worked in surgical and infection control devices, digital health, and cardiovascular devices, according to a report from Stat, citing anonymous sources.
Steven Grossman, a regulatory consultant with HPS Group, said in an email that probationary employees, who are either in their first few years of government service or promoted in a competitive recruitment, seem to have been targeted in the wave of job cuts.
“Beyond that, the process seems like it was arbitrary,” Grossman wrote. “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.”
