In an abrupt decision, part of the Trump administration’s push for a leaner government, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health lost an estimated 200 to 240 employees — many of these employees being the very experts responsible for reviewing the complex, cutting-edge medical devices that define modern healthcare.
Among a series of repercussions, the biggest consequence of these massive F.D.A. layoffs is a slower medical device approvals process — not by weeks, but by months or even years. “We’ve heard from folks who have already gotten notice that current applications may be delayed or suspended,” said AdvaMed CEO Scott Whitaker. Even before these mass firings, device approval timelines were already a concern. Now, with hundreds of reviewers gone, companies waiting on AI-driven diagnostics, cardiovascular implants, and next-generation diabetes monitoring devices are stuck in limbo. Attorney Jason Brooke, who represents digital health firms, was scheduled for a 510(k) pre-submission meeting at the F.D.A. the day after the firings. But when he called in on the day of the scheduled meeting, he got a chilling response: the three subject matter experts assigned to the meeting had all been let go.
The F.D.A. layoffs not only create a bureaucratic hurdle but also possibly jeopardize timely access to life-saving treatments. It’s not just approval delays that matter. Of all the areas affected, artificial intelligence and digital health technologies are among the biggest casualties of these F.D.A. cuts. A significant portion of the C.D.R.H. staff affected by the layoffs were experts in AI, machine learning, cybersecurity, and digital health, which remain relatively uncharted territory for the F.D.A., making the agency’s Q-submission process a crucial resource for medtech companies seeking regulatory guidance on their innovations.
Jay Vaishnav, director of regulatory affairs at Canon Medical Informatics and former acting associate director at C.D.R.H.’s Office of Science and Engineering Laboratories, emphasized the high stakes of regulatory delays: “In industry, time is money, and predictability is just as crucial as speed.”
Assigning non-specialists to review complex algorithms and machine-learning models presents two immediate serious risks. First, it could lead to overly cautious, prolonged reviews, stalling innovation, and delaying patient access to life-saving technologies. Second, it raises the likelihood of rushed or poorly informed approvals, allowing unsafe devices to slip through the cracks.
The United States has long been the global leader in medtech innovation. But with an F.D.A. that is suddenly short-staffed, overwhelmed, and uncertain, companies may start looking elsewhere — Europe and Asia — for quicker approvals.
In recent years European regulatory agencies, bolstered by the comprehensive E.U. General Data Protection Regulation, have begun to outpace the rest of the world in approving certain technologies, particularly AI-powered medical devices. Hollowing out the F.D.A.’s workforce is making it just as hard for U.S. companies to compete as it is effortless for global rivals to pull ahead.
Now, in a move that lays bare the recklessness of these cuts, the F.D.A. is scrambling to rehire many of those same employees. The damage, however, is already done. These layoffs didn’t just disrupt operations; they shook the very foundation of trust in federal institutions by sending a clear message to public servants: their jobs, no matter how critical, can be sacrificed at any moment for political optics.
The F.D.A. isn’t the only agency caught in DOGE’s chaotic purge-and-rehire cycle. In recent weeks, mass layoffs have hit federal agencies across critical sectors, including public health, national security, and environmental oversight.
A government that treats its workforce as disposable without due consideration could not expect to retain the expertise and commitment of public servants that are necessary for effective governance. The repeated cycle of mass firings, emergency rehirings, and political interference has eroded the very foundation of federal institutions — and with it, the confidence of the professionals who could serve the public.
Would top scientists, public health experts, and crisis managers stay in roles where they can be fired at any moment for political gain? The answer is simple: they won’t. And when the best and brightest leave government service, American people aren’t just losing individual employees and their services.
The Zeitgeist aims to publish ideas worth discussing. The views presented are solely those of the writer and do not necessarily reflect the views of the editorial board.
