Part 814 - Premarket Approval (PMA)

Part 814 of Title 21 CFR outlines the Premarket Approval (PMA) pathway for high-risk medical devices, detailing the data, testing, and clinical evidence manufacturers must submit for FDA review. It describes the application components, review timelines, and criteria for approval, denial, or request for additional information, establishing the regulatory framework for devices that require the most rigorous premarket evaluation.