The U.S. Food and Drug Administration (FDA) has approved significantly fewer high-risk medical devices in early 2025, following substantial workforce reductions at the agency's Center for Devices and Radiological Health (CDRH).
Data shows that approvals for high-risk medical devices plummeted to just nine in the first quarter of 2025, marking a ten-year low. This decline is particularly concerning as it comes despite an increase in pending applications compared to the previous year.
Widespread Layoffs Impact FDA Operations
In February, the FDA eliminated more than 220 positions at the CDRH, according to reports from the Associated Press. While some employees were subsequently rehired, many experienced reviewers were not brought back, creating significant operational disruptions.
The situation worsened on April 1, when the Department of Health and Human Services (HHS), which oversees the FDA, implemented another round of job cuts. An HHS spokesperson confirmed to the Minnesota Star Tribune that approximately 10,000 employees were affected by this "dramatic restructuring" across the department.
"This overhaul is about realigning HHS with its core mission: To stop the chronic disease epidemic and Make America Healthy Again," the spokesperson stated. "Despite spending $1.9 trillion in annual costs, Americans are getting sicker every year, and we must shift course."
Impact on Medical Device Reviews
The staffing reductions have had immediate consequences for the medical device industry. Beyond the decline in high-risk device approvals, classifications for novel, lower-risk devices have also fallen to their lowest first-quarter level in five years.
Current and former FDA employees report growing inefficiencies, inadequate support, and a significant loss of institutional knowledge as experienced personnel depart. These challenges have created a backlog that threatens to delay patient access to innovative medical technologies.
Industry Concerns Mount
Medical technology companies and industry associations have expressed alarm about the situation. Medical Alley Association, a healthcare and medical technology trade group whose partners include Medtronic, issued a statement highlighting their concerns.
"We are concerned that the loss of both experienced leadership and emerging professionals will threaten the agency's ability to fulfill its mission — potentially slowing progress, delaying approvals, and undermining public trust in critical health infrastructure," the association stated.
The group emphasized that the FDA has long set the "global gold standard for protecting public health, backed by science and rigorous oversight over medical innovations."
Implications for Companies and Patients
For medical technology companies, FDA approval represents a crucial milestone that enables wide commercialization of new technologies and provides guidance for financial forecasting. The approval process for high-risk devices is already lengthy, requiring extensive premarket testing data to satisfy regulatory requirements.
With the current staffing shortages, companies now face increasingly unpredictable regulatory timelines, making it more difficult to plan product launches and forecast revenue. This uncertainty could potentially discourage investment in innovative medical technologies.
Operational Challenges Within the Agency
Remaining FDA reviewers are reportedly struggling with heavier workloads and declining morale, which could affect both the quality and speed of device assessments. Some industry analysts warn that if these issues persist, the FDA's reputation as a reliable regulatory body may be compromised.
The workforce reductions come at a time when the medical device industry is experiencing rapid technological advancement, with increasingly complex devices requiring specialized expertise for proper evaluation.
Long-term Consequences
If the current situation continues, experts suggest there could be far-reaching consequences for the U.S. healthcare system. Delays in approving innovative medical devices could limit treatment options for patients and potentially put the U.S. at a competitive disadvantage in the global medical technology market.
Some industry observers have expressed concern that companies might increasingly look to other regulatory jurisdictions, such as Europe or Asia, for initial product approvals if FDA timelines become too unpredictable.
As the situation evolves, both the medical device industry and patient advocacy groups are closely monitoring the FDA's capacity to fulfill its regulatory mission amid these significant organizational changes.
