Healthcare Dive, MedTech Dive and BioPharma Dive collaborated on this five-part series examining changes at the HHS one year after sweeping layoffs. The series explores impacts across the department and provides inside looks at the CDRH, CMS, CDC and FDA.
Medical device regulators at the Food and Drug Administration are overworked and understaffed following mass cuts last year and several key departures.
A year ago, the Trump administration slashed thousands of workers across the Department of Health and Human Services. At the FDA’s device center, staff were targeted in rounds of firings in February and April.
People who worked at the Center for Devices and Radiological Health were unsure whether their jobs would be cut or if there would be more reductions in the future. Staff first learned they were being fired when their badges to get into the office no longer worked, according to previous reporting by MedTech Dive. They received emailed notices with inaccurate information, such as the wrong office listed or incorrect performance review scores.
People working at the FDA were advised to take their computer home every night because the next day they might not be able to get back into the office, said Rhonda Mecl, former deputy director of the FDA’s Medical Device and Radiological Health Inspectorate, who worked at the agency until August 2025.
“It was a horrendous era,” Mecl said.
Since then, the FDA’s medical device center has been bleeding staff, as longtime employees have taken early retirements or left for other jobs. Some high profile losses include Ross Segan, former director of the Office of Product Evaluation and Quality, who was caught up in the February 2025 firings; Douglas Kelly, former deputy science director, who departed in March 2025; and Melissa Torres, former associate director for international affairs, who left for a new job in February.
In a point of stability, CDRH Director Michelle Tarver has remained at the agency, while other FDA center directors have left or been forced out.
The cuts and attrition have left CDRH workers with large workloads and little support, former employees told MedTech Dive. Attorneys and consultants who work closely with the CDRH also are concerned about the loss of experienced leaders, which has led to communication challenges and inconsistent feedback.
“Generally, we're starting to see the cracks show at FDA,” said Kelliann Payne, a partner at law firm Hogan Lovells who specializes in medical devices.
The HHS did not answer MedTech Dive’s multiple requests to provide a current employee count for the CDRH. Typically, the center discloses how many workers it has in its annual report, but the 2025 report did not include any such number.
Between September 2024 and January 2026, the FDA lost about 21% of its workforce, or more than 4,400 people, according to data from the Office of Personnel Management. The data did not include numbers specifically for the CDRH.
The cuts created a “culture of fear and anxiety” at the FDA, said Sean Boyd, vice president of QualityHub and former director of CDRH’s Office of Regulatory Programs.
Many people at the agency’s device center were eligible to retire or decided to leave, said Boyd, who worked at the FDA for more than 30 years before retiring in April 2025. After a long career with the U.S. Public Health Service Commissioned Corps, Boyd had planned to retire and return to his same job at the CDRH as a civilian, but his offer was rescinded during a February 2025 hiring freeze.
Not only has the center’s talent pool been depleted, but its institutional memory and culture have been “severely diminished,” Boyd added. The CDRH lost leaders who rose through the ranks of the organization, and were focused on innovation and improvements that had an impact on patient safety and product quality.
“People are just focused on getting done what they must get done,” Boyd said, “given the culture shift that has occurred over the last year.”
Philip Desjardins, a partner at law firm Arnold & Porter, estimated that CDRH would not have had so many voluntary departures if it weren’t for the job instability that people felt, particularly in the first half of 2025.
The HHS declined to provide additional details or comments on the job cuts.
Rapid and arbitrary cuts
Last year’s cuts were “rapid, arbitrary, and not based on any analysis of how the agency could succeed with fewer employees,” Steven Grossman, president of the consultancy HPS Group and author of FDA Matters, wrote in an email. The cuts were driven by individuals with no understanding of the agency rather than by senior leadership, and recent hires were fired regardless of their role, Grossman believes.
In February 2025, the Trump administration cut hundreds of probationary workers, a designation typically used for people who have been at the FDA for less than two years. While many of these people were called back, damage had been done with low morale, loss of expertise and lack of clear guidance from senior leadership, Grossman wrote.
Another round of cuts in April targeted regulatory, administrative and communications roles.
Boyd said the offices within the CDRH that were hit hardest by the cuts were the Office of Management, which supports staffing, travel and budget; and the Office of Communication, Information Disclosure, Training and Education, which is responsible for public communications, employee training, industry and consumer education. The Office of Regulatory Programs, where Boyd worked, was also affected, although some staff were brought back, he said.
Son Nguyen, special counsel at the law firm Cooley, likened the cuts to “a complicated, intricate puzzle that had been put together and someone just came along and took out the pieces.”
From conversations with current staff, people working at the agency “feel overwhelmed and uncertain” and morale seems to be low, added Nguyen, who worked at the FDA for more than a decade, ending in 2023.
Even the most committed people start to burn out and the most dedicated people reluctantly start making compromises.
Steven Grossman
President of HPS Group
Grossman wrote that many staff stay at the FDA for the mission and the sense of making a difference. Having fewer people taking on the workload is not a viable long-term strategy.
“Even the most committed people start to burn out and the most dedicated people reluctantly start making compromises,” Grossman wrote.
An FDA reviewer, who was granted anonymity so they could speak freely without fear of retribution, told MedTech Dive that they knew of several divisions that no longer have team leads, because they all left to work in industry.
“People are all going to burn out at some point,” said the reviewer. “Whether it be front line reviewers or their managers, everyone’s doing more work than they normally would do.”
Conflicting communication
Attorneys and consultants who work with the CDRH worry that the pace of work may be unsustainable. They also have noticed more difficulty getting meetings with center staff and less consistent feedback on applications in the past year.
“I am very, very concerned, because I just don't see how the agency can continue to do all that it needs to do in this very demanding space, while at the same time it is consumed with day-to-day responsibilities, and while, at the same time, it is operating against staffing losses and retrograde policy practices that make smart regulation difficult,” said Steve Silverman, president of the Silverman Group consultancy, which serves medtech firms on regulatory, strategy and policy. Silverman previously led the CDRH’s Office of Compliance in 2015.
So far, the FDA’s device center has been on track for key metrics, according to the CDRH’s annual report. The report said the center is poised to meet targets for review timelines “despite resource challenges.” CDRH authorized 124 new devices last year, on par with 2024.
One consequence of the staff losses has been changes to decisions mid-application. Cooley’s Nguyen said that with some clients, new staff came in while a premarket review was pending, and they took a more conservative approach that was contrary to the positions of the former reviewers.
Jason Brooke, managing member and attorney with Brooke & Associates, said that meetings ahead of medical device submissions, also known as Q-submissions, are becoming less valuable as companies receive conflicting information. For example, in one case, a client received feedback around an analysis of AI performance in a Q-submission meeting, but a year later, the agency changed its expectations around performance targets. Other companies have received conflicting information, Brooke said, adding that in the worst case, this can lead to lost time in device development.
Experts also said feedback on device applications can feel rushed. Arnold & Porter’s Desjardins said that in the past year, clients have been receiving less feedback, such as less detailed deficiency letters for 510(k) clearance applications. Companies have been notified about the deficiencies but don’t have the information needed to respond adequately, Desjardins said.
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.
Kelliann Payne
Partner at Hogan Lovells
Hogan Lovells’ Payne said she has received feedback as late as two days before a device is cleared, with last-minute requests on labeling changes. This is challenging because device sponsors have to largely agree to the changes or not get cleared, Payne said.
“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.
Investigators burned out
Compliance actions such as inspections, recall communications and warning letters have not slowed despite the staff cuts. The CDRH issued 59 warning letters and posted 110 recall communications in 2025, more than the prior year.
Within the CDRH, the people who conduct medical device reviews also do postmarket work, including helping classify recalls and track adverse events. They work with investigators at the FDA’s Office of Inspections and Investigations, or OII, who inspect medtech facilities and examine complaints.
Mecl, the former medical device inspectorate deputy director, said the number of inspections of medical products has been consistent between 2025 and previous years. However, there were fewer foreign inspections last year, which may have freed up more time for domestic inspections. Medical products include medical devices, drugs, biologics and bioresearch monitoring.
Mecl said investigators, who are driven to the FDA’s mission, may compensate for the smaller workforce by taking on more hours and responsibilities.
“They’re taking on additional burdens and increasing personal sacrifices,” Mecl said. “But we may be burning them out.”
The HHS has not shared a total number for how many staff are currently at OII, but CBS News reported in April 2025 that about 170 people were cut from the office. Mecl said that OII has lost several senior staff, with just three of the original eight medical products directors and deputies remaining. The office also lost administrative and training staff, Mecl said.
Investigators who were traveling for inspections had thousands of dollars of credit card bills because when they returned, there was nobody to process their expenses, Mecl said. Between February 2025 and April 2025, investigators had to get individual approvals to travel for work.
“When they were saying FDA can still do inspections, the reality was they handcuffed us; we couldn’t get in a vehicle and couldn’t get in an airplane,” Mecl said.
Those restrictions have since been lifted.
Can the CDRH hire back lost staff?
The FDA is starting to post jobs again after a federal hiring freeze last year. HHS spokesperson Andrew Nixon told MedTech Dive that the FDA is hiring “more than 1,000 reviewers, inspectors and investigators,” but did not respond to multiple requests for a number for the CDRH. As of March 25, just 13 FDA jobs were posted to the federal government’s employment site, USAJobs.
Even with new hires, it will take time to build back the device center. It takes about two to three years to train and onboard new reviewers, QualityHub’s Boyd said.
You’re trying to do the best you absolutely can for sure, but there’s only so much that you, a single person, can do.
Current FDA reviewer
Center for Devices and Radiological Health
The FDA reviewer consistently hears of staff leaving the agency. The more people leave, the harder it’s going to get for whoever stays, the FDA reviewer said.
“You’re trying to do the best you absolutely can for sure, but there’s only so much that you, a single person, can do,” they said.
Silverman credited the staff at the CDRH, including Tarver, for working under “extremely difficult circumstances.”
“I don't think that the potential negative impact of staff losses on FDA generally, and CDRH included, can be understated,” Silverman said.
He expects the damage from last year’s cuts will have a lasting effect “over years to come.”
