The U.S. Food and Drug Administration has significantly reduced its workforce at the Center for Devices and Radiological Health (CDRH), with more than 220 jobs cut in February and additional staff reductions in April. While some employees were rehired, many reviewers were not, contributing to operational disruptions. As a result, approvals for high-risk medical devices declined to nine in the first quarter of 2025, marking a ten-year low. This drop comes despite an increase in pending applications at the end of 2024 compared to the year prior. Classifications for novel, lower-risk devices also fell to their lowest first-quarter level in five years. Current and former FDA employees report growing inefficiencies, a lack of support, and a loss of experienced personnel, creating delays and uncertainty for both patients and medical technology companies.
Industry leaders and Analysts have raised concerns about the impact of these staffing changes on the agency’s ability to review devices effectively. The changes have left remaining reviewers with heavier workloads and lower morale, potentially affecting the quality and speed of device assessments. Companies are facing unpredictable regulatory timelines, making it harder to plan and forecast revenue. Some experts warn that if these issues persist, the FDA's reputation as a reliable regulatory body may be at risk.
