Code of Federal Regulations Title 21, Volume 8, April 1, 2015

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