What's Happening?
The Center for Devices and Radiological Health (CDRH), part of the Food and Drug Administration (FDA), has released its first annual report following significant staff reductions implemented by the Trump
administration. Despite these cuts, the CDRH has managed to maintain its review timelines and authorize a substantial number of medical devices. In 2025, the center authorized 124 novel medical devices, an increase from 120 in the previous year, and received 21,780 submissions, up from 20,727. However, the report did not disclose the current staffing levels, which have reportedly decreased by about 22% from 2024. The CDRH has also issued fewer policy documents, with only 21 guidances released compared to 38 in the previous year. The center is currently negotiating the next five-year Medical Device User Fee Amendments (MDUFA) agreement, which will determine future funding and staffing levels.
Why It's Important?
The ability of the CDRH to maintain its review timelines despite reduced staffing is crucial for the medical device industry, which relies on timely approvals to bring new products to market. The increase in device authorizations and submissions indicates a growing demand for medical innovations. However, the reduction in policy guidances could slow the introduction of new regulatory frameworks, potentially affecting the development and approval of emerging technologies, such as AI-enabled devices. The ongoing negotiations for the MDUFA agreement are critical, as they will set the financial and operational parameters for the CDRH, impacting its capacity to handle future workloads and maintain its role in safeguarding public health.
What's Next?
As the CDRH continues to negotiate the MDUFA agreement, stakeholders in the medical device industry are closely monitoring the outcomes, which will influence the center's funding and staffing capabilities. The expansion of pilot programs, such as the Technology-Enabled Meaningful Patient Outcomes (TEMPO), suggests a shift towards integrating real-world data in regulatory processes. Additionally, the focus on AI-enabled devices and digital health solutions indicates a potential area for future regulatory developments. The industry is also awaiting further guidance on cybersecurity and AI, which are becoming increasingly relevant as technology advances.
