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One of President Donald Trump’s priorities since taking office involves reducing the size of the federal government. In February, President Trump signed an executive order to optimize the government workforce and a month later, the U.S. Department of Health and Human Services (HHS) acted on the directive by announcing it would slash about 3,500 full-time FDA employees to streamline operations and centralize administrative functions.
The layoffs focused on probationary workers, who include new hires with less than two years of service or established staff members who have recently moved into new positions. HHS said the staffing reduction would not affect medical device reviewers or inspectors.
In early April, HSS Secretary Robert Kennedy Jr. announced plans to reinstate about 20% of workers who were let go during the widespread layoffs.
Still, the Trump administration’s desire to restructure the federal workforce has raised questions and concerns about the review timeline for orthopedic devices coming to market, the continued development of emerging technologies and FDA inspections of orthopedic manufacturers. Here’s what we know so far.
Quality Inspections
Dan Goldstein, Senior Director of Quality Assurance at MCRA, said FDA quality inspections of orthopedic device manufacturers are continuing as planned. He shared that one of MCRA’s clients recently endured an inspection that lasted 20 days and stretched across two months because of concerns raised by the inspectors.
Interestingly, the inspection began with two investigators. One of them, however, was let go almost immediately due to their provisional status. That individual was later rehired and eventually brought back as part of the inspection team.
All of this underscores an important point, according to Goldstein: Despite internal disruptions, FDA has enough resources to complete scheduled inspections.
“We’re actively supporting clients undergoing inspections right now, which shows that part of the agency is still fully operational,” he said.
Domestic and foreign orthopedic manufacturers should continue to assume that FDA could inspect them at any time.
“Regardless of location, we’re advising all our clients to be prepared for an inspection, just as they would have been last year,” Goldstein said. “The current situation hasn’t changed that reality.”
Goldstein also said FDA’s Freedom of Information Act (FOIA) office has been functioning more smoothly than expected. FOIA responses are governed by regulation, requiring the agency to respond within a set timeframe.
“In practice, the office often misses imposed deadlines,” Goldstein said. “However, in multiple situations I’ve personally been involved in, FOIA has not only been on time but in some cases, even early.”
Device Reviews
Peter Pitts, President and Co-founder of the Center for Medicine in the Public Interest, said FDA’s layoffs have not yet impacted the review of orthopedic devices. However, he believes it’s likely that delays will occur in the future.
“Fewer staff members are now handling the same workload, so it’s reasonable to expect bottlenecks,” Pitts said. “These delays could influence future user fee negotiations, although there’s been no indication that FDA’s overall approach to reviewing orthopedic devices is changing. The fundamental regulatory philosophy remains in place. It’s simply a matter of fewer workforce resources handling the same, if not increasing, demand.”
Pitts noted that even when staffing cuts don’t directly impact reviewers, losing support staff — secretarial, administrative or technical — adds to the workload reviewers must carry. That can slow the process and spread reviewers thinner.
He expressed concerns about the long-term impact of the layoffs and believes mounting workloads could be a longer-term issue that affects FDA staffing levels. “A smaller team of reviewers who have more devices to review creates the potential for burnout,” Pitts said.
Pitts advises orthopedic companies to be proactive in their response to the layoffs by assuming delays are not just possible, but likely, and building them into project timelines and regulatory strategies.
For now, Goldstein believes orthopedic companies should hold device reviewers to the same standards that were in place before the layoffs.
“If one of my clients wasn’t receiving a response from FDA within a reasonable timeframe, I wouldn’t chalk it up to the current situation. I’d go straight to the ombudsman,” he said. “The fact that offices like FOIA are functioning normally tells us the agency is still capable of operating as expected.”
Impact on AI
Stat reports that the 2,000 employees cut from the Center for Devices and Radiological Health (CDRH) involved staff who focus on regulating artificial intelligence (AI) and digital health programs.
“Many of the laid-off workers were probationary employees, who tend to be newer and younger,” Pitts said. “The agency is letting go of people who are more comfortable dealing with new types of technologies, and talented prospects could be deterred from joining in the future.”
Scott Whitaker, AdvaMed President and CEO, responded to the staffing cuts with worries about how they will impact future innovation.
“We understand and support the administration’s overall goal to be more efficient with the taxpayer dollar,” Whitaker said. “Our concern is that this round of cuts to FDA staff runs counter to that shared goal.
“AI in healthcare is a clear, illustrative example,” he continued. “Eliminating FDA’s recent critical new hires in the AI space will dramatically slow review times and require reassigning non-experts already at FDA to review these technologies who will inevitably make slower and potentially inappropriately conservative decisions.
Whitaker believes it is critical that the process of getting new and promising technologies to physicians and patients not be put at risk.
“A strong and effective FDA is an essential element of that process,” he said. “Patients’ lives, as well as our nation’s global leadership in medtech innovation, manufacturing and jobs are potentially at stake.”
Future Concerns
Whitaker believes medical device reviews were already too long. Still, FDA had been making the review process more efficient, transparent and predictable to streamline the steps necessary to bring new products to market. He said the staffing cuts could jeopardize the progress FDA has made in recent years.
“But there remains time to change course,” Whitaker added. “Working together, we can achieve a more efficient and effective FDA.”
The full impact of the layoffs hasn’t yet been realized, according to Goldstein. “They’re going to be felt eventually through a loss of expertise,” he said, “but it takes a while for that to percolate throughout the agency.”
For example, Goldstein wondered whether FDA would have enough experts on staff to review Premarket Approval applications.
“The agency might not choose to convene the required panel because they don’t have people to sit on it,” he said. “That’s not known at this point, but it is plausible.”
Orthopedic companies must move forward based on what’s currently happening. Inspections and device reviews are on schedule — so far. Stakeholders throughout the orthopedic industry are hoping it remains that way.
“In orthopedics, time matters,” said Ryan Belaney, President and CEO of Phoenix Kinetics, and President of the Orthopaedic Surgical Manufacturers Association (OSMA). “Every delay in the regulatory process represents patients living with pain or limited mobility longer than necessary. Maintaining a robust review infrastructure ensures that American patients have the same timely access to innovative treatments as patients elsewhere in the world.”
During this week’s OSMA Spring Business Meeting, member companies will discuss how recent HHS changes might impact their ability to bring novel medical devices to patients.
“This collaborative forum exemplifies how OSMA harnesses the collective expertise of the orthopedic community to proactively address challenges and ensure continued innovation for patient care,” Belaney said.
This article is part of the OSMA Insights series. Look for the next installment in the June issue of BONEZONE Magazine.
