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Code of Federal Regulations

Subchapter H

Medical Devices

800General 801Labeling 803Medical Device Reporting 806Medical Devices; Reports of Corrections and Removals 807Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices 808Exemptions from Federal Preemption of State and Local Medical Device Requirements 809In Vitro Diagnostic Products for Human Use 810Medical Device Recall Authority 812Investigational Device Exemptions 813[Reserved]814Premarket Approval of Medical Devices 820Quality Management System Regulation 821Medical Device Tracking Requirements 822Postmarket Surveillance 830Unique Device Identification 860Medical Device Classification Procedures 861Procedures for Performance Standards Development 862Clinical Chemistry and Clinical Toxicology Devices 864Hematology and Pathology Devices 866Immunology and Microbiology Devices 868Anesthesiology Devices 870Cardiovascular Devices 872Dental Devices 874Ear, Nose, and Throat Devices 876Gastroenterology-Urology Devices 878General and Plastic Surgery Devices 880General Hospital and Personal Use Devices 882Neurological Devices 884Obstetrical and Gynecological Devices 886Ophthalmic Devices 888Orthopedic Devices 890Physical Medicine Devices 892Radiology Devices 895Banned Devices 898Performance Standard for Electrode Lead Wires and Patient Cables