The Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has presented a picture of remarkable operational stability in its 2025 annual report, successfully maintaining its core device review functions despite navigating significant internal pressures and substantial staff reductions implemented by the Trump administration. This resilience, however, appears to come at a cost, with a notable slowdown in policy development and a conspicuous lack of transparency regarding its current workforce numbers. The report highlights a strategic pivot toward prioritizing tasks with the most direct impact on public health, a move that has allowed the center to keep pace with an increasing number of submissions and even slightly surpass its previous year’s total for novel device authorizations. While the headline figures suggest business as usual, a deeper analysis reveals an agency making difficult trade-offs to fulfill its primary mandate amidst challenging resource constraints, raising critical questions about the long-term sustainability of this high-pressure operational model.
Sustained Performance and Strategic Pivots
A detailed examination of the 2025 data reveals that the CDRH not only managed its workload but also demonstrated a capacity for growth in key areas. The center authorized 124 novel medical devices, a modest but significant increase from the 120 authorized in 2024. This achievement is particularly noteworthy given that it coincided with a higher volume of submissions, which climbed to 21,780 from 20,727 the previous year. According to CDRH Director Michelle Tarver, this sustained output was the result of a deliberate strategy to concentrate efforts on activities with the “greatest impact on patients and public health.” This prioritization has enabled the center to remain on track to meet crucial review timeline targets established under the Medical Device User Fee Amendments (MDUFA V), an agreement with the industry that sets performance goals. The ability to meet these commitments, even while openly acknowledging “resource challenges,” underscores the center’s adeptness at reallocating its internal capacity to protect its most visible and time-sensitive functions from disruption.
In stark contrast to the steady pace of device reviews, the CDRH’s policy development activities experienced a significant deceleration in 2025, reflecting both the internal prioritization of resources and a broader deregulatory push by the administration. The center issued only 21 policy guidances, a sharp drop from the 38 released in the preceding year. This reduction suggests that long-term strategic planning and regulatory clarification may have been sacrificed to meet the immediate demands of the review pipeline. Nevertheless, the center did advance several critical policy initiatives, issuing a final guidance on cybersecurity requirements for premarket submissions and releasing draft guidances on the performance of pulse oximeters and the evaluation of AI-enabled medical software. Furthermore, the CDRH launched new programs aimed at fostering innovation, including the TEMPO pilot for digital health devices and an expanded early alert system for high-risk recalls, signaling that while the volume of policy work has decreased, its focus remains on high-priority and emerging technological areas.
Unanswered Questions and Future Concerns
One of the most significant and concerning aspects of the 2025 CDRH report is its complete omission of workforce data. Unlike reports from previous years, the document fails to provide any figure for the number of employees at the center. This lack of transparency is a stark departure from 2024, when the CDRH reported a staff of 2,260. The absence of this key metric makes it difficult to fully assess the agency’s operational health and the strain on its remaining personnel. This omission is particularly troubling when viewed in the context of an earlier ProPublica report, which indicated that the center had lost approximately 22% of its workforce through a combination of administrative cuts and employee departures. Without current staffing numbers, stakeholders are left to speculate on the true human cost of maintaining the center’s impressive review metrics and whether the current pace is sustainable without risking employee burnout and a potential decline in review quality over the long term.
The strategic decisions and workforce challenges detailed in the 2025 report have set the stage for a period of intense scrutiny from stakeholders across the healthcare landscape. While the CDRH demonstrated an ability to meet its immediate obligations, the trade-offs made have created uncertainty about its future capacity. The slowdown in policy guidance could create ambiguity for manufacturers developing next-generation technologies, potentially hindering innovation. Moreover, the unresolved questions surrounding its workforce cast a shadow over its long-term stability. Industry observers are now closely monitoring the agency’s next steps, particularly in rapidly evolving fields like artificial intelligence. The recent convening of a digital health advisory committee to discuss complex technologies such as AI-powered therapy chatbots underscores the mounting pressure on the agency. The center’s performance in 2025 was a testament to its focus and efficiency, but it also highlighted a precarious balancing act that may prove difficult to maintain in the years ahead.
