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Medical Devices
Law
CFR 21
Food and Drugs
Food and Drug Administration, Department of Health and Human Services
Medical Devices
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Part
800
General
Part
801
Labeling
Part
803
Medical Device Reporting
Part
806
Medical Devices; Reports of Corrections and Removals
Part
807
Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
Part
808
Exemptions from Federal Preemption of State and Local Medical Device Requirements
Part
809
In Vitro Diagnostic Products for Human Use
Part
810
Medical Device Recall Authority
Part
812
Investigational Device Exemptions
Part
813
Part 813 [Reserved]
Part
814
Premarket Approval of Medical Devices
Part
820
Quality System Regulation
Part
821
Medical Device Tracking Requirements
Part
822
Postmarket Surveillance
Part
830
Unique Device Identification
Part
860
Medical Device Classification Procedures
Part
861
Procedures for Performance Standards Development
Part
862
Clinical Chemistry and Clinical Toxicology Devices
Part
864
Hematology and Pathology Devices
Part
866
Immunology and Microbiology Devices
Part
868
Anesthesiology Devices
Part
870
Cardiovascular Devices
Part
872
Dental Devices
Part
874
EAR, Nose, and Throat Devices
Part
876
Gastroenterology-Urology Devices
Part
878
General and Plastic Surgery Devices
Part
880
General Hospital and Personal Use Devices
Part
882
Neurological Devices
Part
884
Obstetrical and Gynecological Devices
Part
886
Ophthalmic Devices
Part
888
Orthopedic Devices
Part
890
Physical Medicine Devices
Part
892
Radiology Devices
Part
895
Banned Devices
Part
898
Performance Standard for Electrode Lead Wires and Patient Cables