One year after sweeping Reductions in Force (RIFs) reshaped the US Food and Drug Administration (FDA), former senior official Sean Boyd says the agency is stabilizing, but stresses that recovering lost expertise will take time.
Boyd, now QualityHub’s Corporate VP, spent 31 years at the FDA before departing amid the workforce reductions. He held a range of roles throughout his tenure there, concluding as Director of the Office of Regulatory Programs in the Office of Product Evaluation and Quality (OPEQ), within the Center for Devices and Radiological Health (CDRH).
In a March interview with the B2B industry publication MedTech Dive, Boyd described the FDA as an organization that has largely moved past the immediate shock of layoffs but is still grappling with the long-term consequences of losing seasoned leadership, institutional knowledge, and internal capacity.
And in recent follow-up comments to QHub Insights, Boyd expanded on his remarks, discussing operational strains, agency culture, and his view that the FDA is on the rebound.
Leadership Gaps and ‘Clawing Back’ Knowledge
Despite the layoffs, the agency didn’t lose all its top leaders, with Boyd pointing to continuity in key roles that helped “steady the ship,” including Michelle Tarver as CDRH Director. Still, a “not insignificant portion” of senior leaders – many with decades of experience – left the agency.
Those departures went beyond titles, he said. Many of the people who exited helped shape CDRH’s culture, built programs still in use today, led major initiatives, and developed the internal relationships needed to steer complex regulatory processes. Boyd said their absence “severely diminished” aspects of the center’s institutional memory and culture.
At the reviewer level, losses were equally significant. Some senior reviewers opted to leave rather than risk uncertainty, taking with them deep expertise in handling complex product submissions, mentoring junior staff, and managing teams. Their departure reduced CDRH’s capacity not only to conduct high-level reviews, but also to coach newer employees and sustain ongoing initiatives.
“Clawing back that institutional knowledge is going to be accomplished through succession planning,” Boyd said, describing how mid-career leaders with 15 to 20 years of experience are stepping into more senior roles. “They’re going to bring their experience … to those new leadership positions that may have been vacated.”
But he emphasized that organizational memory built over decades cannot be quickly replaced. “It would take years to replenish that,” he said.
Strain on Training, Operations, and Review Capacity
Last year’s departures also created operational challenges across multiple functions. Boyd pointed to disruptions in communication, education, and administrative support – areas often less visible but critical to the agency’s effectiveness.
RIFs within the FDA’s communication and education offices, as well as various operational teams, have hampered the agency’s ability to consistently develop and update guidance and safety communications for industry and the public, though he noted those functions are gradually returning to normal.
Training has been particularly affected. While industry-facing education programs required under user-fee commitments have continued, internal training infrastructure has thinned. Training initiatives such as the Reviewer Certification Program may now rely more heavily on recorded materials rather than in-person instruction, as well as fewer experienced staff to mentor new hires.
“There are fewer people to handle complex reviews who also have the responsibility to train up new review staff,” Boyd said. “If you’re faced with limited resources and more priorities than you can handle, something needs to give.”
While the FDA lost talent, the broader medical device ecosystem may benefit. Many former agency staff have moved into industry or consulting roles, bringing with them valuable regulatory insight.
The longstanding two- to three-year ramp-up period for new reviewers has not necessarily changed, but the environment around it has. With fewer senior staff, the tension between training responsibilities and the need to complete complex reviews has intensified.
Operational gaps have also emerged in administrative areas such as travel and internal support services, where staffing reductions or consolidation into shared service groups have shifted responsibilities onto remaining staff, potentially slowing internal processes.
Despite these pressures, Boyd said recent data suggest the agency’s MDUFA (Medical Device User Fee Amendments) performance has held up. Review timelines and on-time decision metrics remain strong, even as staffing levels adjust.
He cautioned against interpreting sustained or improved efficiency metrics as evidence of reduced scrutiny, noting there is no indication that review quality has declined. Industry feedback and user-fee performance data support that view. However, Boyd acknowledged that outside observers may question whether faster timelines reflect increased efficiency or other tradeoffs.
Recent positive negotiations between the MedTech industry and the FDA regarding the latest user-fee amendments – MDUFA VI – also signal stability. Boyd described those user-fee commitments as a “freight train” the agency is unlikely to slow given their importance to both regulators and manufacturers.
Even with leadership and staff departures, he expressed confidence in those who remain.
People still at CDRH, Boyd said, remain deeply committed to the agency’s public health mission, with patient safety and product quality at the forefront. However, the loss of experienced individuals has increased the burden on remaining staff to maintain those standards while adapting to a disrupted workforce.
He likened the current operating environment to past high-pressure periods, such as the COVID-19 public health emergency or previous government shutdowns, when the agency prioritized its most critical responsibilities.
A Cultural Shift that Ultimately Benefitted Industry?
Immediately following the RIFs, the agency experienced “fear and anxiety” as employees faced uncertainty about their futures, Boyd said in the MedTech Dive interview. One year later, that atmosphere has largely subsided.
“It’s certainly not at the level that it was last year,” he said. “People have accepted reality and adjusted.”
Boyd now characterizes the agency’s environment as one of adaptation and gradual normalization, with staff focused on “getting done what they must get done,” he told MedTech Dive.
Still, the layoffs may have lasting implications for recruitment. Government service, once widely seen as a stable career path, may no longer carry the same perception among prospective employees given the combination of hiring freezes and workforce reductions, which Boyd said were unprecedented in his career in terms of their scope and lack of flexibility.
The full impact of the FDA’s workforce reductions will unfold over years as it works to restore the experience base that once defined its leadership ranks.
“If I’m a recent college grad,” he said, “I’m not necessarily going into a role at the FDA thinking this is a 100% secure position.”
Boyd noted that while the agency lost talent, the broader medical device ecosystem may benefit. Many former FDA staff have moved into industry or consulting roles, bringing with them valuable regulatory insight.
“That person can now help industry navigate and meet agency expectations in ways that somebody who doesn’t have that FDA experience could do,” he said, adding that cross-pollination between regulators and industry can improve mutual understanding, with each side gaining insight into the other’s constraints and priorities.
A Glimmer of Optimism
Despite ongoing challenges at the FDA, Boyd remains cautiously optimistic, citing current hiring efforts and steady regulatory output as early signs of recovery.
“They appear to be doing fine,” he said. “The agency is rebuilding and carrying on the good work that my former colleagues were – and are – completely committed to.”
Even so, he reiterated that the full impact of the workforce reductions will unfold over years, not months, as the FDA works to restore the experience base that once defined its leadership ranks. For now, the effects remain uncertain, still taking shape beneath the surface – measured not in reports or announcements, but in the slow return of expertise.
