In a surprising display of resilience, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) not only maintained its operational tempo but also increased its authorization of novel medical devices in 2025, a period marked by significant staff reductions under the Trump administration. The center’s first annual report since the workforce cuts revealed a strategic pivot, with efforts intensely focused on work deemed to have the greatest public health impact. This performance stands in stark contrast to the backdrop of internal resource challenges and a conspicuous lack of transparency regarding its employee numbers. While the output metrics suggest a year of high productivity, the underlying data raises critical questions about the long-term sustainability of this pace and the potential trade-offs made in other crucial areas, such as policy development, to achieve these results. The situation has left industry stakeholders and public health advocates scrutinizing the agency’s ability to uphold its dual mandate of fostering innovation and ensuring patient safety under duress.
Navigating Unprecedented Resource Challenges
A Surge in Submissions and Approvals
Despite facing what the agency termed “resource challenges,” the CDRH demonstrated remarkable productivity in its core review functions throughout 2025. The center successfully authorized 124 novel medical devices, a notable increase from the 120 approved in the preceding year. This accomplishment is even more significant when considering the concurrent rise in the center’s workload, which saw total submissions climb to 21,780 from 20,727 in 2024. This data indicates that the agency managed to process a higher volume of applications while simultaneously navigating the complexities of groundbreaking technologies. Furthermore, the report highlighted the continued success of programs designed to expedite access to critical innovations. A total of 149 devices were granted a breakthrough designation, a status reserved for technologies that may provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. Of these, 44 breakthrough-designated devices ultimately received authorization, underscoring the center’s commitment to prioritizing and advancing promising medical solutions for patients.
The ability of the CDRH to manage this escalating workload was largely attributed to a strategic prioritization of its activities. By concentrating its efforts on submissions with the most significant potential for public health impact, the center was able to allocate its strained resources more effectively. This approach ensured that the most critical and innovative devices moved through the review pipeline efficiently, ultimately reaching patients who needed them most. This focus is a core component of the Medical Device User Fee Amendments (MDUFA V), an agreement with the industry that sets specific performance goals for review timelines. The 2025 report confirmed that despite the internal pressures, the CDRH was on track to meet these key MDUFA V targets. This performance suggests a highly adaptive and resilient operational model, capable of adjusting to external pressures without compromising its primary mission of timely device review. However, this success in one area has led to questions about what other responsibilities may have been de-emphasized to achieve these impressive metrics in the face of significant personnel shortages.
The Shadow of Workforce Reductions
A significant point of concern arising from the 2025 report was the stark lack of transparency surrounding the CDRH’s staffing levels. In a departure from previous annual reports, the document conspicuously omitted any mention of workforce totals. This omission was particularly jarring given that the center had reported a staff of 2,260 employees in 2024. Compounding this ambiguity, a spokesperson for the Department of Health and Human Services declined to provide the current figure when questioned. This silence occurred in the wake of a ProPublica report which indicated that the CDRH had lost approximately 22% of its workforce, a substantial reduction that would invariably impact its operational capacity. The decision to withhold this fundamental data point has fueled speculation and concern among stakeholders, who rely on such information to assess the health and capabilities of the agency responsible for overseeing the nation’s medical device supply. The lack of clear communication on this critical issue undermines confidence and raises questions about the agency’s long-term stability.
The issue of staffing is not merely an internal administrative matter; it is a foundational component of the regulatory framework. The MDUFA V agreement, which provides a significant portion of the center’s funding through industry user fees, explicitly ties that funding to the FDA’s ability to hire and retain a sufficient number of qualified reviewers and support staff. An adequately staffed center is essential for conducting thorough, timely, and scientifically rigorous reviews that protect public health. While the CDRH managed to meet its MDUFA V review timeline goals in 2025, the unreported reduction in its workforce introduces a critical variable. Operating with a significantly smaller team places immense strain on the remaining employees and could lead to burnout, loss of institutional knowledge, and potential oversights. The central question that emerged was whether this high level of output was sustainable or if it represented a short-term surge achieved at the expense of staff well-being and the thoroughness of regulatory oversight in the long run.
A Shift in Regulatory Focus and Future Outlook
Deceleration in Policy and Guidance
While the CDRH excelled in its device review throughput, its activity in policy development experienced a noticeable slowdown in 2025. The center issued only 21 guidance documents during the year, a sharp decline from the 38 guidances released in 2024. This reduction in regulatory output aligns with the broader deregulatory agenda pursued by the Trump administration, which favored a less prescriptive approach to agency oversight across various sectors. Guidance documents are a critical tool for the FDA, as they provide industry with the agency’s current thinking on regulatory issues, helping manufacturers navigate the complex premarket submission process and ensure compliance. The deceleration in their issuance suggests a strategic shift, where the center’s limited resources were consciously directed away from proactive policy-making and toward the more immediate, mandated task of clearing the queue of device submissions. This trade-off, while successful in meeting review timelines, could create future uncertainty for device developers, particularly those working on the cutting edge of technology.
Despite the overall reduction in policy output, the CDRH did take targeted action on several key fronts, indicating a strategic, rather than a wholesale, retreat from guidance development. Among the most significant actions was the release of a final guidance on cybersecurity for premarket submissions, a critical step in addressing the growing threat of cyberattacks on connected medical devices. The center also issued important draft guidances, including one aimed at improving the accuracy and equity of pulse oximeters and another addressing the unique challenges of regulating AI-enabled medical software. In addition to these policy documents, the agency expanded a pilot program for delivering early recall alerts to the public and launched an innovative new program for digital health devices called TEMPO. This program is designed to facilitate the collection of real-world data, potentially streamlining the regulatory process for certain digital health technologies. These specific initiatives demonstrate that even with reduced capacity, the center remained focused on addressing pressing contemporary issues in medical technology.
The Road Ahead for Medical Technology Regulation
As 2025 concluded, the CDRH had successfully weathered a year of immense pressure, maintaining its core function of device review in the face of significant, albeit officially unconfirmed, staffing cuts. The agency’s ability to increase its novel device authorizations while managing a larger volume of submissions was a testament to its strategic prioritization of high-impact work. This performance, however, came at the cost of a slower pace in policy development, creating a potential vacuum in regulatory clarity for emerging technologies. Stakeholders were left to weigh the immediate benefit of faster device approvals against the long-term risk of a less-defined regulatory landscape. The year’s events solidified the view that the center was operating under a new paradigm, one that emphasized reactive review over proactive guidance. This shift left the medical device industry and patient advocacy groups watching closely for future actions, particularly in rapidly evolving fields that demand clear and forward-thinking oversight.
The most pressing question that carried over into the new year concerned the future of regulating artificial intelligence in medical devices. While the center had issued a draft guidance, the full scope of a regulatory framework for these complex, often adaptive, technologies remained undefined. The challenges posed by AI—including issues of algorithmic bias, transparency, and validation of “black box” systems—required a level of nuanced and sustained policy engagement that seemed at odds with the center’s recent focus. The industry needed clarity to innovate responsibly, while the public needed assurance that these powerful new tools were safe and effective. The trajectory of AI regulation stood as a key test for the CDRH, representing a critical area where its ability to balance innovation with safety, under continuing resource constraints, would be most profoundly judged by all stakeholders involved in the healthcare ecosystem.
