Experts: FDA layoffs will slow device reviews, impact decision making

Recent mass layoffs at the US Food and Drug Administrations (FDA) by the Trump Administration will hinder the agency's reviews of new devices and result in the agency failing to meet the user fee goals outlined in the Medical Device User Fee Act (MDUFA), according to legal experts who spoke to Focus.

The layoffs appear to disproportionately affect different divisions within the FDA’s Center for Devices and Radiological Health (CDRH). Smaller divisions will feel the impact of these cuts more severely than larger divisions, which employ more staff, according to experts. Additionally, these layoffs will make employees wary of making controversial approval decisions.

On 15 February, numerous probationary staff at FDA began receiving emails notifying them they had been fired. Most of the firings were directed at CDRH. (RELATED: Firing of FDA probationary staff creates widespread uncertainty, Regulatory Focus 17 February 2025).

Michael Gaba, vice chair of the FDA practice group for the law firm Polsinelli, said that 200 device staff were laid off over the weekend, and out of those, 50% of those jobs were funded in part by user fees. Most, if not all, of those laid off were probationary employees hired within the past one or two years. Focus contacted the FDA to confirm the number of layoffs, but did not receive a response by the time of publication.

These staff losses mean that it will take FDA longer to review applications and will likely miss review goals specified under MDUFA, though Gaba said he anticipates that some of the fired probationary employees will challenge their terminations.

What struck Gaba the most about this action was the broad-brush nature of the firings. “There is nothing strategic about these cuts,” he said.

One of those laid off was Ross “Rusty Segan, the recently hired director of the Office of Product Evaluation and Quality (OPEQ).

“For somebody who counsels device companies on all things premarket and postmarket, [OPEQ] is the most important office within CDRH and they just removed the person who runs it.”

This move “sends a message to everyone one in that office to the reviews, that if he is removed then we are all at risk,” Gaba said.

Gaba stated that these firings will make the remaining employees hesitant to make controversial review decisions. “I believe they will try to keep a low profile, and the less controversial their decisions are, the better. They likely won’t want to draw attention to themselves.” They will also be more cautious about being overly aggressive as regulators.

This means that employees may be reluctant to impose postmarket requirements on new devices or impose additional clinical study requirements for certain devices.

Gaba believes that the purpose of the firings was to save government money on salaries, but may also have the effect of intimidating employees from being overly aggressive.

“These actions were taken quickly and were driven by President Trump's desire to fulfill his campaign promise. He understands that he has a limited time frame, and the margin in the House is very narrow. There is a real risk that the House could flip in two years, and without the trifecta, he won't have a complacent Congress standing on the sidelines as he does today.”

Cuts will be felt differently across CDRH

Richard Lewis, a principal expert in regulatory devices and biologics at Hyman, Phelps, and McNamara, said the impact of these cutbacks will be felt differently across the centers. In larger review divisions with 50 staff members, losing one person will not significantly affect the overall workload. However, in smaller more specialized teams of reviewers, the loss of one or two members will have a substantial impact.

Yet Lewis cautioned that it is too early to know yet which divisions were the most affected by the job losses. “I think we’ll have to wait for the dust to clear to find out what groups actually had a lot of people leave and to see how the FDA will handle those workloads,” he said.

Steven Grossman, president of HPS Group and author of the FDA Matters blog, agreed that it is too soon to know how many people were affected by the weekend purge, and said “we will know more once the situation stabilizes.” Grossman was the former director of the Alliance for a Stronger FDA.

According to Grossman, the Department of Health and Human Services (HHS) announced that there would be approximately 5,200 layoffs, including around 1,300 at the CDC. Yet said Grossman, “I've recently seen two other figures that differ from both 5,200 and 1,300.” He said there is still much uncertainty about the final headcount—both those being let go and those who will remain. “It is impossible to talk about either general or specific impacts. We need to let the dust settle,” he added.

“For those of us who are watching, it is frustrating not to know. For FDA employees--those who are living it—it is probably closer to excruciating,” Grossman said.

Stuart Pape, the food and drug law chair at Polsinelli, said the recent turmoil is causing a level of stress that is “off the charts” for FDA employees personally and professionally. He said that “there’s a great deal of uncertainty. The person who was on the team you worked with is no longer employed. They were fired over the weekend.”

He added that these are not scenarios “that permit people to work normally.”

Experts: FDA layoffs will slow device reviews, impact decision making

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