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Seeking Feedback to Inform GenAI-Enabled Medical Devices Regulatory Approach

Seeking Feedback to Inform GenAI-Enabled Medical Devices Regulatory Approach

By issuing a discussion paper and seeking public feedback, the FDA is launching a transparent process to inform the development of an approach that safeguards patients and consumers, advances innovation, and serves as a potential model for regulators around the world.

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FDA in Action

FDA Weighs in on the Development and Use of Digitally Derived Measures for Clinical Investigations
FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma
Supporting and Strengthening Domestic Drug Manufacturing
The FDA at 120: A Long, Distinguished History Protecting Americans
Accelerating and Modernizing Early and Late-Stage Clinical Development
Year 1 Goals in Reducing Animal Testing in Drug Development
Results from Largest-Ever Testing of Infant Formula in the U.S.
FDA PreCheck Pilot Program: Strengthening Domestic Pharmaceutical Manufacturing
Food Chemical Safety Post-Market Assessment Program and Reassessment of BHT, ADA

Press Announcements

August 25, 2026

FDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar

August 19, 2026

FDA Approves First Therapy for Patients aged 8 years and older with Glycogen Storage Disease Type Ia

August 19, 2026

FDA Authorizes First-Of-Its-Kind Robotic Blood Draw Device

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