MINNEAPOLIS — U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as sources say recent layoffs have had devastating effects.

Federal data show the regulatory agency — which has fired hundreds and rehired an unknown number of device reviewers and administrative staff at the Center for Devices and Radiological Health (CDRH) — only approved nine new or substantially changed high-risk medical devices in the three-month period, down from 13 in 2024 and 14 the year before. The lower number of reported decisions is happening even though the agency had more applications for high-risk devices pending on Dec. 31, 2024, than by the same date in 2023.

The apparently slower performance comes as industry observers worry that CDRH staffing changes will slow down product reviews, which already can last years. Financial analysts say companies are uncertain how the cuts will affect regulatory timelines, which help determine future financial projections. Minnesota is home to hundreds of medical device companies that can’t sell new technologies or produce revenue without FDA review.

A federal official did not answer questions about the cause of the decline, but said the “FDA is committed to ensuring medical devices are safe and effective for Americans before they reach the market.”

Device reviewers who spoke to the Minnesota Star Tribune said the agency has been less efficient since job cuts in February and again last week.

“It was really, really devastating,” said a staff fellow and lead reviewer in the CDRH about being put on administrative leave, who declined to be named out of fear of employment retaliation. “I really enjoyed my work. I loved the mission of trying to keep these medical devices safe for everybody who’s gonna use them.”

Classifications for reported “de novo” medical devices, which tend to be lower-risk and novel, declined to a five-year low for the first quarter, according to a separate database. Pending applications for these devices without direct predecessors in regulatory files, though, also declined to a five-year low, according to quarterly performance reports.

The hundreds of medical device companies in Minnesota rely on timely FDA review processes to begin producing revenue for new technologies.

Medical Alley Association, a local health care and medtech trade association with partners such as Medtronic, said in a statement that the FDA has long set the “global gold standard for protecting public health, backed by science and rigorous oversight over medical innovations.”

“We are concerned that the loss of both experienced leadership and emerging professionals will threaten the agency’s ability to fulfill its mission — potentially slowing progress, delaying approvals, and undermining public trust in critical health infrastructure," the statement continued.

Former FDA officials estimated a February round of job cuts eliminated more than 220 jobs from the CDRH, the Associated Press reported. Some employees were rehired. The Department of Health and Human Services (HHS), which encompasses the FDA and other health-related agencies, launched another round of job cuts on April 1, slashing an estimated quarter of its staff.

In an email to the Minnesota Star Tribune last week, an HHS spokesperson said roughly 10,000 employees were affected by the most recent reduction in force, referring to it as a “dramatic restructuring” in accordance with an executive order.

“This overhaul is about realigning HHS with its core mission: to stop the chronic disease epidemic and Make America Healthy Again,” the spokesperson said. “Despite spending $1.9 trillion in annual costs, Americans are getting sicker every year, and we must shift course.”

An FDA approval is a hard-won milestone allowing a medtech company to widely commercialize life-changing technology and set guidance for future financial performance. It can take years for the agency to approve a new high-risk technology in part because companies must generate reams of data from premarket testing to satisfy FDA reviewers.

Now, the gap between pending applications and premarket approval decisions has appeared to widen, according to quarterly performance reports and the agency’s premarket approval database. Devices approved for commercialization under this rigorous process include Medtronic’s adaptive technology personalizing treatment of Parkinson’s symptoms using advanced stimulation deep in the brain.

While de novo classifications decreased to three for the January to March period — down from 12 last year and 10 in 2023 — the gap between pending applications and classifications remains in line with that reported the year before, according to the performance reports and a separate database tracking de novo classifications. Products cleared through the de novo process, such as Apple’s hearing aid technology for AirPods, tend to be novel low- to moderate-risk devices.

The datasets were last updated Monday. The HHS official didn’t say whether the way the agency maintains the regulatory data has changed.

The official said layoffs “relate to administrative staff positions in the FDA.”

“The agency will focus on streamlining operations and centralizing administrative functions as part of HHS’ transformation initiative to make the agency more efficient and responsive,” the official continued. “The reduction did not affect drug, medical device, or food reviewers, nor impacted inspectors. The critical work will continue.”

One employee on administrative leave said regulators who remain on staff have more work on their plates due to the cuts and nowhere to ask questions after support staff were laid off. The source said reviewers who are tired, upset and scared about their job security might not be as diligent in a “job that requires a lot of attention to detail.”

“I can’t imagine a less-efficient approach than what the administration has already done,” the source continued.

The reviewer was at the FDA for a year and a half and set to end a probationary period in September. After being placed on leave in mid-February, their government ID stopped working, and access to a work laptop was cut off. The reviewer said they were one of numerous reviewers who was not rehired, but the administrative leave has lengthened due to court orders: “I’m getting paid, but I’m doing nothing.”

“I was hoping that I was going to be there until retirement,” the reviewer added.

A second reviewer said, “What’s happening at FDA is awful. It’s setting us back and making us less effective.” The changes are a detriment to patients and the companies “trying to make their lives better,” the reviewer said.

Dr. Ken Ouriel, director of key opinion leaders at medtech consulting group NAMSA, said it’s too early to tell whether there’s a change in reviewers’ pace, “but it would be intuitive that it would take longer when there are fewer people.”

At a NAMSA webinar earlier this month, Dr. Jeffrey Shuren, the longtime chief device regulator at the FDA who left his post last summer, said he wouldn’t be surprised “if we saw longer review times, at least in the near term.”

A Medtronic spokesperson said in a statement that the Fridley-run company is aware of the staff reductions and is “assessing any impact to the review of our programs. ” Morningstar analyst Debbie Wang said she’s concerned that companies with applications will see delays.

“I don’t know that we can count on the same kind of timeline that has been more predictable in the past,” Wang said.

Former Medtronic chief executive Art Collins said health care CEOs may wonder how long FDA job cuts and tariffs, simultaneously pummeling the industry, will stay in place.

“It creates a very uncertain environment and it’s difficult to plan,” Collins said, “particularly for decisions that will roll out over an extended period of time measured in years, not days or months.”

Shuren said some of the premarket review staff whose terminations were later rescinded decided not to return to the agency. Other reviewers still at the agency said they are looking to leave.

“The administration has done an excellent job at deterring people from wanting to work in the government,” the reviewer on leave said, adding that a mass exodus from the agency is anticipated.

Shuren said he hopes changes don’t compromise the rigor of the FDA.

“Having robust science to inform decision-making has really been the lifeblood for the agency,” Shuren said.

Collins said other countries have viewed the FDA as the “standard for regulatory compliance around the world” up until this point.

Now, he said, many wonder: “Will the FDA be in fact the gold standard in the future?”

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(MaryJo Webster of the Minnesota Star Tribune contributed to this report.)

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