This story has been updated to note that the Trump administration appears to have reversed a number of planned CDRH staffing cuts, including to reviewers hired with funding provided by industry user fees under MDUFA V.
NEW YORK – Staff cuts announced last week at the US Food and Drug Administration's Center for Devices and Radiological Health (CDRH) were poised to hamper the agency's ability to review medical device submissions, including for diagnostics and laboratory-developed tests (LDTs), in a timely fashion, said industry stakeholders.
But following pushback from organizations, including medical device manufacturer trade group AdvaMed, the Trump administration appears to have reversed a number of the planned CDRH layoffs.
"Coming out of the weekend, it appears a sizable number of expert reviewers will return to FDA," said AdvaMed President and CEO Scott Whitaker. "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."
The CDRH cuts had been part of a wave of layoffs that occurred last weekend affecting thousands of employees across the US Department of Health and Human Services (HHS). Since President Donald Trump took office roughly a month ago, his administration has let go large numbers of "probationary" employees (typically meaning workers still within one year of their hiring date) throughout the government.
An industry source said that between 220 and 230 individuals within CDHR had been laid off, including between 120 and 180 employees hired with funds provided through the most recent Medical Device User Fee Amendment, MDUFA V, which was signed into law in 2022. MDUFA agreements establish the fees medical device firms pay the FDA to fund review of their submissions and establish hiring requirements and review timelines that the agency is expected to meet. MDUFA V requires that the FDA meets certain annual hiring requirements or else return funds to industry via lower fees. It also established new timelines cutting the time for decisions on 510(k) and premarket approval submissions by 20 days.
Whitaker said during a Wednesday press event that the staffing increases mandated by MDUFA V were likely a factor in the large number of cuts at CDRH as the center had a number of recent hires that were still in their probationary period.
He added that the cuts' focus on recent hires means that newer areas of emphasis like AI have been hard-hit.
"That's [something] we're trying to help the administration understand," he said. "If your intent was to cut some of the fat out of an agency, the result of your action is not that. It's to cut the newest employees with the most specialized skills relative to emerging technologies, particularly in the digital and AI space."
Whitaker said it is not yet clear what activities within the FDA will be most impacted but noted that "when you see there are 200-plus people who are no longer there, it raises a lot of questions about what they were working on."
"We'll probably get a better picture in the coming days as to what will be impacted," he said. "It's fair to assume that many things will be, but we're not certain yet exactly what."
He said that AdvaMed has heard from device firms that have received notices from the FDA that current applications may be delayed or suspended.
The FDA did not respond to a request for the exact number of CDRH staff that had been laid off or a request for comment on how the cuts might affect its ability to meet the staffing and review timeline benchmarks set by MDUFA V.
The CDRH cuts also come as the FDA continues to roll out its rule on LDTs, with the first set of reporting requirements under the rule set to go into effect this spring.
Even before the recent staff cuts, many in the clinical lab industry questioned whether the agency has sufficient resources to handle the increased workload involved in LDT oversight.
AdvaMed has long advocated for a regulatory approach to LDTs that would bring them under FDA oversight while at the same time reforming regulation of both LDTs and in vitro diagnostics in a way that would move them out of the medical device regulatory framework and into a regulatory framework tailored specifically to diagnostics.
Whitaker said he isn't sure if or how the CDRH cuts might affect AdvaMed's approach to the issue.
"I wouldn't say we've changed our position or the forcefulness of our advocacy based on this yet," he said.
James Boiani, an IVD, drug, and medical device life sciences attorney at Epstein, Becker & Green in Washington, D.C., said that he anticipates the cuts will result in slowdowns across the submission and review process.
"I would expect that pre-submission meetings and early discussions with the agency would be the initial victims in terms of slowed response times," he said. "Eventually, it could hit marketing authorizations like 510(k)s and de novo submissions where they are just going to start missing deadlines unless there is something done to ameliorate the staffing shortage, whether that is bringing in contractors or trying to outsource some work to third parties or something like that."
Boiani said, however, that from a legal perspective, device firms have limited options for addressing missed decision deadlines. While there are statutory provisions requiring the agency to issue decisions within certain time frames (90 days for a 510(k), for instance), compelling the FDA to make those decisions would require going to court, which, he noted, "takes some time in itself."
Whitaker said AdvaMed hopes to avoid taking the matter to court.
"We don't want to go down the litigation route," he said. "The goal in the next couple of days is to fix [the situation] so you can avoid that conversation. We're very squarely focused on the MDUFA side right now to see if we can clean that up a little bit. If it isn't fixed and there are a large [number] of MDUFA employees that are impacted by [the cuts], then we're going to have to consider what we do about it, either through Congress or through other means."
Boiani suggested that the cuts, if they stand, could substantially impact negotiations over the next MDUFA renewal, which is slated for 2027. He noted that the MDUFA program, which first went into effect in 2002, was in large part motivated by industry concerns that the FDA's medical device reviews were taking too long due to insufficient staff.
"I expect that Congress will want to keep [user fees], because that is how they fund a lot of the agency, but … user fees have gone up every year, and if the agency is not performing well enough to meet the goals [established by MDUFA], it would be hard to justify increasing fees further," he said. "The extreme would be that you just don't have user fees."