510(k), PMA, and De Novo Explained: Ultimate Guide to FDA Device Approval Pathways Mastering 510(k), PMA, and De Novo: Compliance-Ready Guide for FDA Device Approvals Introduction to 510(k), PMA, and De Novo Pathways The 510(k), Premarket Approval (PMA), and De Novo pathways are the three primary routes for obtaining FDA approval or clearance to market medical devices in the United States. Each pathway addresses different risk classes and device categories, ensuring safety and performance before commercialization. By 2025, these pathways are increasingly shaped by digital submissions (eSTAR), real-world evidence, and accelerated review options. Understanding their requirements is vital for medical…