FDA 21 CFR Subchapter-H Medical Devices Regulations


FDA 21 CFR Subchapter-H Medical Devices Regulations:

FDA 21 CFR Subchapter-H Medical Devices Regulations:

Click the titles below for complete guidelines

Table of contents

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       [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

FDA 21 CFR Subchapter H Medical Devices Regulations:

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