CDRH 2025 Annual Report

The United States Food and Drug Administration (FDA) Center for Devices and Radiological Health’s (CDRH) mission is to protect and promote public health while supporting timely access to innovative, safe, and effective medical devices and safe radiation-emitting products.  This includes evaluating devices with innovative medical technologies, supporting manufacturers in delivering high-quality devices, and advancing safety through rigorous oversight.  Anchored on the pillars of safety and innovation, the CDRH 2025 annual report highlights the Center’s resilience and sustained performance this past year.

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Highlights include:

• Strengthened safety and quality through initiatives like the Early Alert Program.
• Fostered innovation and brought important new technologies to patients, including authorizing one of the highest annual totals of novel medical devices in the Center's more than 40-year history.
• Convened a Digital Health Advisory Committee focused on generative-AI enabled digital mental health medical devices.
• Announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot to promote access to certain digital health devices while safeguarding patient safety.
• Continued our focus on performance and kicking off negotiations for MDUFA VI.

Questions?

If you have questions, contact the Division of Industry and Consumer Education (DICE).