FDA’s Breakthrough Devices Program provides expedited interaction and prioritized review for eligible medical devices intended to treat or diagnose life-threatening or irreversibly debilitating diseases or conditions.

FDA has published a discussion paper seeking stakeholder feedback on regulatory considerations for generative AI-enabled medical devices, including risk assessment, premarket evaluation, benchmarking, clinical confirmation, postmarket monitoring and foundation models.

FDA opens the FY2027 MDUFA Small Business Request window on August 1, 2026. Learn eligibility rules, user fee discounts, and submission steps.

FDA expands its TAP Pilot with more devices and new areas. Key updates and what medical device manufacturers need to know.