13. Medical Device FDA Regulation & Registration

Medical-device FDA regulation and registration encompass the establishment, product, quality, and post-market requirements governing devices distributed in the United States. This topic explains which manufacturers, importers, sterilizers, relabelers, and other establishments must register; how registration differs from device listing and premarket authorization; and when distributors or other businesses may be exempt. It also covers annual registration fees and renewal, 510(k), De Novo and PMA pathways, principal provisions of Title 21 CFR, the 2026 Quality Management System Regulation, and packaging-validation requirements for sterile and nonsterile devices. Regulatory responsibilities must be determined from the device classification, intended use, establishment activities, and applicable product-specific controls.