Amanda Pedersen, Senior Editor
February 18, 2025
6 Min Read
President Donald Trump smiles as Robert F. Kennedy Jr. delivers remarks after being sworn in as Secretary of Health and Human Services in the Oval Office at the White House on February 13.Image credit: Andrew Harnik/Getty Images
Updated to include a recent statement from AdvaMed CEO Scott Whitaker on the recent cuts to FDA's workforce.
Medtech should brace for longer medical device approval timelines as FDA takes a major hit just days after Robert F. Kennedy Jr. (RFK Jr.) was confirmed as the new U.S. Secretary of the Department of Health and Human Services (HHS).
Hundreds—if not thousands—of employees across HHS, including staff at FDA, the Centers for Disease Control (CDC), and the National Institutes of Health (NIH), were caught up in the first wave of layoffs. While the total number of employees impacted is unclear, some officials on Friday expected HHS to fire 5,200 probationary employees across its agencies, the Associated Press reported, citing an audio recording of an NIH department meeting.
Cuts at FDA hit people who do research and approvals on the medical device side of the agency (Center for Devices and Radiological Health), NPR reported, citing "fired employees who were fearful of the consequences of speaking out."
The layoffs don't come as a huge surprise, given that Kennedy has been promisingsweeping changes to the healthcare system since before he was even officially nominated for the job.
The NPR also explained that probationary status applies to new employees or those who have moved to new positions within the agency within the past one to two years. The news outlet said it reviewed termination letters sent to staff across all three healthcare agencies and noted that all of them used similar language, citing inadequate performance as the reason for their firing, even though the employees NPR spoke with reportedly had stellar work records. The letters set a termination date effective March 14, 2025.
Related:Former Medtronic CEO: Kennedy’s HHS Leadership Is ‘Quadruple Threat’
AdvaMed CEO pleads for a reversal of FDA cuts
Scott Whitaker, president and CEO at AdvaMed, raised concerns about the round of cuts to FDA staff and makes a case for HHS to change course.
"We understand and support the administration’s overall goal to be more efficient with the taxpayer dollar. Our concern is that this round of cuts to FDA staff runs counter to that shared goal," Whitaker wrote.
He cites the industry's latest user-fee agreement with FDA that, for the first time ever, created private sector-like incentives for FDA to be more efficient, transparent, and predictable in its review process. The idea behind this was to make leading-edge medical technologies and treatments available to American patients sooner while still ensuring the safety of the products being approved.
Related:‘We’re Going to Eliminate an Entire Alphabet Soup of Departments and Agencies’
"Unfortunately, as a result of these reductions, FDA will lose hundreds of new employees, the best and most innovative hires under our most recent agreement," Whitaker wrote. "But there remains time to change course. Working together, we can achieve a more efficient and effective FDA. But, on behalf of our members, I am concerned that the cuts made over the weekend will not accomplish that. I am also concerned that it puts at risk our nation's status as the top medtech market in the world
—as the global leader in medtech innovation, manufacturing, and jobs."
Whitaker also points out that eliminating FDA's recent critical hires in the AI space will dramatically slow review times and require reassigning non-experts that remain on staff to review these technologies. These non-experts in AI will, Whitaker says, "inevitably make slower and potentially inappropriately conservative decisions."
He said he sent a letter to HHS today outlining AdvaMed's concerns.
"I hope we are able to work with Secretary Kennedy, his leadership team, and that of FDA to reverse these cuts and then put our heads together on policies that will achieve the aims of President Trump and
DOGE
but without putting patients and America's leadership role in medtech at risk," he wrote.
Related:FDA Chaos Threatens America’s First-to-Market Advantage
Medtech reacts to FDA workforce cuts
LinkedIn is flooded with posts from impacted employees and their colleagues reacting to the layoffs.
"The magnitude of posts is not just incredibly sad but alarming. Clinicians, engineers, scientists, and highly specialized subject matter experts have all been impacted. These people had answered our country’s call to serve the American public and did so with expertise, professionalism, dignity, and integrity. The loss of these individuals from the FDA workforce and the way this cut was implemented will have lasting impacts," writes Matthew Hazelett, chief regulatory officer at MedSec, and a former FDA worker. "Not only have talented, hardworking civil servants been terminated, but the American people are now more likely to have delayed access to the new and updated treatment devices, diagnostic tools, and monitoring capabilities that medical device manufacturers (MDMs) are trying to make available."
Hazelett's post goes on to say that the layoffs will "undoubtedly affect submission review timelines" and that if one of the impacted employees was the lead or consulting reviewer on your file, they likely did not have the opportunity to handoff their files before their system access was removed.
"My office in CDRH was not spared from the purge that happened this weekend," writes Julie Sullivan, a director within CDRH’s Office of Radiological Health. "We lost some really excellent people in the radiological health space who are now looking for work. ... They’re adaptable, innovative, and hardworking."
"What happens when the gatekeepers of medical device regulation are suddenly shortstaffed? What happens when the FDA no longer has a seat at the table where ISO standards are being written? Delays and bottlenecks make sense... And so does a more selective—and possibly more aggressive—regulatory approach," writes Etienne Nichols, one of MD+DI's 24 Medtech Voices to Follow and head of industry insights and education at Greenlight Guru.
Not only does Nichols point out that fewer regulators mean longer review timelines, he also suggests that the medical device industry could see a shift in FDA's priorities.
"Which programs will take the biggest hit? Breakthrough devices? 510(k) reviews? This could reshape regulatory pathways as we know them," Nichols writes.
Medtech has 'gotta step up'
Perhaps more important than speculating on how the HHS layoffs will impact medical device manufacturers from a regulatory standpoint, Nichols' post is also a call to action for the industry.
"Companies that take control of their regulatory strategy will set the tone for the industry," he writes.
That means there's no room for rework, so submissions need to be airtight the first time, according to Nichols. It also means that medtech companies must fill the knowledge gap by maintaining strong regulatory teams or partnerships for better internal expertise. It also means more industry-led collaboration, he explains.
"If the FDA is stretched thin, medtech leaders gotta step up. The companies that share insights, set standards, and drive best practices will define the future," Nichols writes. "This isn't the time to wait and see. It's time to adapt, anticipate, and lead."
