21 CFR Parts 800 to 1299 covers the U. S. Food and Drug Administration within the U.S. Department of Health and Human Services. Within this volume, you will find rules, procedures, and regulations pertaining to medical devices, such as cardiovascular devices, dentistry devices, orthopedic, gastroenterology-urology, in vitro, anesthesiology, and more. Plus, you will find rules, procedures, and regulations relating to mammography quality standards, radiological health, tobacco products, human tissue intended for transplantation, and more. Health care device manufacturers, hospital radiological and other medical technicians and departments, physicians, nurses, out-patient clinics’ personnel, and health care policy advocates may be interested in this volume.
Code of Federal Regulations Title 21, Volume 8, April 1, 2015
Containing parts Parts 800 to 1299
Part 800; GENERAL Part 801; LABELING Part 803; MEDICAL DEVICE REPORTING; (Eff. Until 8-14-15) 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 Part 900; MAMMOGRAPHY Part 1000; GENERAL Part 1002; RECORDS AND REPORTS Part 1003; NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY Part 1004; REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS Part 1005; IMPORTATION OF ELECTRONIC PRODUCTS Part 1010; PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL Part 1020; PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS Part 1030; PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS Part 1040; PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS Part 1050; PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS Part 1107; ESTABLISHMENT REGISTRATION, PRODUCT LISTING, AND SUBSTANTIAL EQUIVALENCE REPORTS Part 1140; CIGARETTES AND SMOKELESS TOBACCO Part 1141; CIGARETTE PACKAGE AND ADVERTISING WARNINGS Part 1150; USER FEES Part 1210; REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT Part 1230; REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT Part 1240; CONTROL OF COMMUNICABLE DISEASES Part 1250; INTERSTATE CONVEYANCE SANITATION Parts 1251-1269; Reserved Part 1270; HUMAN TISSUE INTENDED FOR TRANSPLANTATION Part 1271; HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS Parts 1272-1299; Reserved
