Former Officials Say FDA Device Center Is Strained a Year After HHS Layoffs

A year after mass layoffs across the Department of Health and Human Services, staff at the FDA's Center for Devices and Radiological Health face heavy workloads and little support, according to former employees and attorneys interviewed by MedTech Dive for a report published on April 1.

"Generally, we're starting to see the cracks show at FDA," said Kelliann Payne, a Hogan Lovells partner who specializes in medical devices. Staff at the device center were targeted in rounds of firings in February and April 2025, and the center has since lost longtime employees to early retirement and other jobs, the outlet reported.

Departures and an unknown head count

HHS did not answer MedTech Dive's repeated requests for a current CDRH employee count, and the center's 2025 annual report did not include one, the outlet said. Between September 2024 and January 2026, the FDA as a whole lost about 21 percent of its workforce, or more than 4,400 people, according to Office of Personnel Management data cited in the report. Those figures were not broken out for CDRH.

Departures named in the report include Ross Segan, former director of the Office of Product Evaluation and Quality, and Douglas Kelly, former deputy science director. CDRH Director Michelle Tarver has remained at the agency.

Sean Boyd, a former director of CDRH's Office of Regulatory Programs who is now a vice president at QualityHub, said the cuts created a "culture of fear and anxiety" at the FDA. An FDA reviewer, granted anonymity by the outlet, said several divisions no longer have team leads because they left for industry. "People are all going to burn out at some point," the reviewer said.

What companies are seeing

Attorneys and consultants told MedTech Dive they have had more difficulty getting meetings with center staff and have received less consistent feedback on applications over the past year. Son Nguyen, special counsel at Cooley, said that in some cases new staff who took over pending premarket reviews took a more conservative approach than earlier reviewers. Arnold & Porter partner Philip Desjardins said clients have received less detailed deficiency letters for 510(k) applications.

"I've been writing premarket submissions and interacting with FDA since the late 90s, and this is by far the most volatile up and down, delays in timing that I've seen," Payne said.

Output holds, for now

By the center's own measures, output has held up. CDRH authorized 124 novel medical devices in 2025, "one of the highest annual totals in the Center's more than 40-year history," according to its 2025 annual report. The report said that "despite resource challenges," the center was on track to meet key review timeline targets under the MDUFA V user fee program. MedTech Dive reported the center issued 59 warning letters and posted 110 recall communications in 2025, more than the prior year.

In the report, Tarver wrote that the year "brought several changes that required us to adjust our pace and focus our efforts," and that "while some of our numbers look different than in past years, they reflect the choices we made to support CDRH staff." Among its 2026 aims, the center said it intends to "strengthen CDRH resilience to adapt to staffing changes."

HHS spokesperson Andrew Nixon told MedTech Dive that the FDA is hiring "more than 1,000 reviewers, inspectors and investigators," but did not give a number for CDRH. Boyd said it takes about two to three years to train and onboard new reviewers.