CDRH Annual Report 2025

The FDA's divisions regularly publish annual reports. The Centre for Devices and Radiological Health (CDRH) has now published its report for 2025. How successful was the FDA in 2025?

Across 12 pages and 9 chapters, the CDRH provides an overview of the year 2025. In the introduction, the Director of the CDRH, Michelle Tarver, reports that 124 new medical devices were 'approved' in 2025. One of the highest rates in its 40-year history. There are also plans to modernise the review of medical devices (MDUFA VI). A newly convened committee on "Digital Health" is intended to promote medical devices using artificial intelligence.

The following achievements are cited for 2025:

• 264,670 medical devices regulated
• 21,780 medical device submissions
• Monitoring of 25,350 medical device manufacturers
• 21 published guidelines
• 125 safety-related communications regarding patient safety
• 11 patient-centred research projects with 38 publications and 8 clinical outcomes in the field of MDDT (Medical Device Development Tools)
• 54% of all premarket approvals based on patient outcomes

In 2025, the FDA supported collaboration between developers, clinicians and patients through a 'Total Product Life Cycle Advisory Pilot Program' (TAP). To date, 108 medical devices have been incorporated into this programme. The Breakthrough Devices Program is also being continued to bring new medical devices to market more quickly. In 2025, 149 medical devices were part of this programme. Furthermore, Elsa is being deployed as an artificial intelligence programme to streamline routine tasks.

To promote the safety and quality of medical devices, the FDA has published the final version of a cybersecurity guidance document. Furthermore, in 2025, the CDRH received 51 notifications of supply shortages. 14 of these required FDA action to mitigate the impact on patients.

Internationally, the CDRH is promoting global cooperation within the International Medical Device Regulators Forum (IMDRF) and through the Medical Device Single Audit Programme (MDSAP). The goal is to include 7 new regions and new countries.

A table in the report shows the CDRH's review times for "approvals". For all "approval types", the 2025 review times were met.

The report concludes with an outlook for 2026. Here, of course, the introduction of the new GMP rules for medical devices (Quality Management System Regulations, QMSR) is mentioned. Furthermore, the report once again highlights the FDA's initiatives on artificial intelligence and digital health. The CDRH brings this together in a Total Product Life Cycle (TPLC) approach, which is intended to support both medical device safety and innovation.

Conclusion: In just 12 pages, the CDRH provides a concise overview of what happened last year in relation to medical devices and offers an outlook for 2026

You can find the report on the CDRH website.