by
Gus Iversen, Editor in Chief | February 03, 2026
The FDA’s Center for Devices and Radiological Health (CDRH) authorized 124 novel medical devices in 2025, including the first blood test to aid in diagnosing Alzheimer’s disease, according to its latest annual report — the total marks one of the highest in the center’s four-decade history.
Alongside device clearances, the CDRH report emphasized a push toward safer, more transparent medical device regulation. Its Early Alert Pilot, expanded to cover all device types, was used to accelerate communication of potentially high-risk recalls. Meanwhile, cybersecurity guidance for manufacturers was finalized to strengthen protections against digital threats to medical devices.
The agency’s innovation initiatives were also in focus. The Breakthrough Devices Program supported the clearance of 44 products, including eyeglass lenses designed to slow pediatric myopia progression. Through its Total Product Life Cycle Advisory Program (TAP) Pilot, the CDRH reported a 98% satisfaction rate among participating device developers. Separately, the Digital Health Center of Excellence launched a regulatory accelerator and convened an advisory committee on generative AI-enabled mental health tools.
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Collaboration with the Centers for Medicare and Medicaid Services led to the launch of the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot, designed to improve access to certain digital health devices while preserving patient safety.
Patient engagement remained a key part of the CDRH’s approach. In 2025, over half of the center’s collaborative communities included direct patient involvement, and 54% of premarket approvals incorporated patient-reported outcomes. The agency also held a town hall focused on older adults' experiences in device clinical studies.
Looking to 2026, the CDRH plans to implement the new Quality Management System Regulation, promote emerging technologies including AI and digital health, and expand postmarket safety efforts. It also aims to optimize compliance and continue adapting to workforce and technology shifts.
