FDA Device Center Lost 22% of Staff and Is Rehiring, Director Tarver Says

The US Food and Drug Administration's Center for Devices and Radiological Health has lost about a fifth of its staff over the past year and is now hiring to recover, center director Dr. Michelle Tarver said on October 21 at AdvaMed's The MedTech Conference in Boston, MedTech Dive reported.

"We've had over the past year-plus about 22% attrition rates," Tarver said, according to MedTech Dive. Some areas have been hit harder than others: the center has lost up to 30% of its clinical reviewers and a significant number of digital health and artificial intelligence specialists, she said.

Hiring against the MDUFA target

Tarver said the device center has hired more than 65 people, exceeding its fiscal 2026 target of 63 under the current Medical Device User Fee Amendments (MDUFA) agreement. The FDA's MDUFA five-year financial plan lists a CDRH hiring target of 63 for fiscal 2026, after 141 hires in fiscal 2023 and a target of 42 in fiscal 2024.

"We have actually exceeded our hiring for fiscal year '26 under the MDUFA commitment, which is a herculean effort considering all the changes that have happened, as well as a testament to people recognizing how much that mission resonates with them," Tarver said.

She added that the center is still awaiting final orders on further hiring. Over the summer, the FDA's acting chief of staff said the agency had been authorized to hire 2,200 people, MedTech Dive reported; that figure was not broken down by center.

"We are not done," Tarver said. "We've got to hire more because we recognize that our center regulates 250,000-plus devices."

Background: the 2025 cuts

Early in 2025, the Department of Health and Human Services announced plans to cut 3,500 FDA staff, about a fifth of the agency, according to MedTech Dive. The publication reported that the cuts were carried out suddenly, that some dismissed staff were later brought back, and that remaining employees faced heavier workloads.

Generative AI guidance expected

Other CDRH officials at the conference also outlined upcoming work. Rick Abramson, director of the FDA's Digital Health Center of Excellence, said on October 20 that the agency intends to issue draft guidance on generative AI-enabled devices within months, MedTech Dive reported. The comment period on an FDA discussion paper on regulating generative AI devices closed on October 19, and the agency had received more than 500 submissions, according to the report.

"This is not just an academic paper. It's not just a thought exercise. We intend to draft policy, and it'll come soon," Abramson said. "This is a priority at the highest levels of the administration," he added, according to MedTech Dive, referring to "the level of the secretary and the White House."

Abramson said finalizing the AI lifecycle management guidance drafted in early 2025 is another priority. He did not commit to a timeline for the generative AI draft, saying the agency needs time to review the comments.