On Thursday, March 27, 2025, HHS announced that they would be conducting a reduction in force impacting nearly 3,500 full time FDA employees – nearly 20% of the Agency’s entire workforce. This comes on the tail end of a layoff in February of this year, when about 700 FDA employees were terminated.
FDA now is grappling with an unprecedented operational shift following these widespread layoffs which is significantly disrupting and impacting its capacity to review and approve new drugs and medical devices. Although we cannot be certain of all the impacts, we can certainly speculate, create reasonable hypotheses, and draw logical conclusions. Furthermore, for many industry stakeholders—Sponsors, clinical researchers, and developers—the ripple effects are already being felt and are now expected to deepen.
At the heart of healthcare innovation is the efficient progression of a product from concept to market. This relies on timely, coordinated regulatory oversight—from preclinical testing protocols and investigational device exemptions (IDEs) to clinical trial design guidance and premarket application reviews. With layoffs throughout FDA, those efficiencies have been severely compromised.
The initial layoffs conducted in February primarily impacted probationary employees, including scientists responsible for ensuring the safety of medical devices related to digital health technologies. This first round of layoffs caused widespread concerns regarding FDA's capacity to effectively review and approve medical products according to the pre-determined timelines.
Among those affected in the more recent layoffs were not just junior reviewers, but also highly experienced leadership-level staff. The departure of senior FDA personnel—those involved in shaping regulatory policy and guiding breakthrough technology decisions—means there will be long-lasting gaps in institutional knowledge. This will particularly affect emerging areas like digital health, where regulatory frameworks are still evolving and often span multiple review divisions.
FDA’s extraordinary staff cuts are already creating turbulence for Sponsors of medical device development programs—and the impacts are likely to deepen in the coming weeks and months. While the financial cost of submissions may not immediately rise, the true cost to Sponsors comes in the form of delayed timelines, limited feedback, and reduced access to regulatory guidance.
The reduction in staff has created bottlenecks across key programs such as:
Early indicators point to a possible increase in deficiency letters, particularly for 510(k) submissions lacking clarity or strategic focus. Simply put: the less buttoned-up your submission is, the more likely it is to be delayed or require multiple rounds of clarification.
Increased workloads are also straining the Agency’s ability to meet statutory timelines. Furthermore, in the absence of experienced hands, new and complex product categories may face the brunt of these delays.
While the cost of submission may not immediately increase, the real burden falls on time—a resource that is often far more critical for Sponsors trying to hit development milestones, fundraising targets, or product launch windows. Every delay in feedback or clearance can reverberate throughout a Sponsor’s commercialization timeline and strategic planning. As many device developers know, time is of the essence, and a delay in reaching the next regulatory milestone can be detrimental to development programs at all stages.
The FDA’s infrastructure was not built for a sudden, large-scale shift back to in-person work. Even basic logistics, such as adequate workspace, have become problematic. Morale and productivity are likely to be affected, especially as the remaining staff must shoulder more responsibilities with fewer resources.
In order to be successful, medical device Sponsors will need to adapt the ways in which they engage with FDA, including:
In the wake of FDA’s layoffs, Sponsors face a regulatory environment defined by longer timelines, diminished feedback, and increased scrutiny. Navigating this uncharted terrain successfully will require more than just compliance—it will require strategic precision, foresight, and the right partners.
Now more than ever, it’s critical for Sponsors to seek guidance from individuals who have deep, firsthand experience with FDA. These may include:
These professionals bring not only regulatory knowledge, but also insight into the unwritten nuances—what kind of language resonates with reviewers, how to structure your questions in a Pre-Sub, and when to push for more versus when to stay aligned with existing guidance.
With reduced review bandwidth, FDA simply cannot spend time unraveling disorganized or unfocused applications. That means submissions must be:
Experienced advisors can help medical device Sponsors identify and correct gaps before submission, prioritize the most critical elements, and anticipate what FDA is likely to question—or flag as deficient.
It is also important for device developers to recognize that these challenges won’t be resolved quickly. The loss of senior reviewers and policy leaders will affect how FDA handles complex, innovative, or first-in-class technologies for the foreseeable future. Partnering with experienced professionals who have navigated regulatory uncertainty before can help teams:
Although it is still early and the full implications of these staffing cuts are yet to be seen, one thing is clear: Sponsors must prepare for a period of increased unpredictability. Bottlenecks in review timelines and the implementation of new regulations for breakthrough technologies are inevitable.
FDA may explore new workload management approaches, such as triaging submissions more strictly or deferring certain types of reviews altogether. Either way, medical device developers must be ready for a more rigid, less consultative, and slower regulatory environment.
The FDA layoffs represent more than an internal HR reshuffle—they mark a pivotal change in how the Agency functions. For Sponsors, success in this new era will hinge on clarity, precision, and deep regulatory insight. Those who adapt quickly and strategically will continue to bring innovation to market; those who don’t risk getting stuck in the backlog.