CFR 21 PART 800-1299 : 2019

800 800.10 to 800.55 GENERAL 801 801.1 to 801.437 LABELING 803 803.1 to 803.58 MEDICAL DEVICE REPORTING 806 806.1 to 806.40 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS 807 807.3 to 807.100 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES 808 808.1 to 808.101 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS 809 809.3 to 809.40 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE 810 810.1 to 810.18 MEDICAL DEVICE RECALL AUTHORITY 812 812.1 to 812.150 INVESTIGATIONAL DEVICE EXEMPTIONS 813 [RESERVED] 814 814.1 to 814.126 PREMARKET APPROVAL OF MEDICAL DEVICES 820 820.1 to 820.250 QUALITY SYSTEM REGULATION 821 821.1 to 821.60 MEDICAL DEVICE TRACKING REQUIREMENTS 822 822.1 to 822.38 POSTMARKET SURVEILLANCE 830 830.3 to 830.360 UNIQUE DEVICE IDENTIFICATION 860 860.1 to 860.136 MEDICAL DEVICE CLASSIFICATION PROCEDURES 861 861.1 to 861.38 PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT 862 862.1 to 862.3950 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES 864 864.1 to 864.9900 HEMATOLOGY AND PATHOLOGY DEVICES 866 866.1 to 866.6080 ANESTHESIOLOGY DEVICES 870 870.1 to 870.5925 CARDIOVASCULAR DEVICES 872 872.1 to 872.6890 DENTAL DEVICES 874 874.1 to 874.5900 EAR, NOSE, AND THROAT DEVICES 876 876.1 to 876.5990 GASTROENTEROLOGY-UROLOGY DEVICES 878 878.1 to 878.5910 GENERAL AND PLASTIC SURGERY DEVICES 880 880.1 to 880.6992 GENERAL HOSPITAL AND PERSONAL USE DEVICES 882 882.1 to 882.5975 NEUROLOGICAL DEVICES 884 884.1 to 884.6200 OBSTETRICAL AND GYNECOLOGICAL DEVICES 886 886.1 to 886.5933 OPHTHALMIC DEVICES 888 888.1 to 888.5980 ORTHOPEDIC DEVICES 890 890.1 to 890.5975 PHYSICAL MEDICINE DEVICES 892 892.1 to 892.6500 RADIOLOGY DEVICES 895 895.1 to 895.104 BANNED DEVICES 898 898.11 to 898.14 PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES SUBCHAPTER I—MAMMOGRAPHY QUALITY STANDARDS ACT 900 900.1 to 900.25 MAMMOGRAPHY SUBCHAPTER J—RADIOLOGICAL HEALTH 1000 1000.1 to 1000.60 GENERAL 1002 1002.1 to 1002.51 RECORDS AND REPORTS 1003 1003.1 to 1003.31 NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY 1004 1004.1 to 1004.6 REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS 1005 1005.1 to 1005.25 IMPORTATION OF ELECTRONIC PRODUCTS 1010 1010.1 to 1010.20 PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL 1020 1020.10 to 1020.40 PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS 1030 1030.1 PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS 1040 1040.10 to 1040.30 PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS 1050 1050.1 PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS SUBCHAPTER K—TOBACCO PRODUCTS 1100 1100.1 to 1100.5 TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY 1105 1105.1 GENERAL 1107 1107.1 ESTABLISHMENT REGISTRATION, PRODUCT LISTING, AND SUBSTANTIAL EQUIVALENCE REPORTS 1140 1140.1 to 1140.34 CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO PRODUCTS 1141 1141.1 to 1141.16 CIGARETTE PACKAGE AND ADVERTISING WARNINGS 1143 1143.1 to 1143.13 MINIMUM REQUIRED WARNING STATEMENTS 1150 1150.1 to 1150.17 USER FEES SUBCHAPTER L—REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION 1210 1210.1 to 1210.31 REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT 1230 1230.2 to 1230.49 REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT 1240 1240.3 to 1240.95 CONTROL OF COMMUNICABLE DISEASES 1250 1250.3 to 1250.96 INTERSTATE CONVEYANCE SANITATION 1251-1269 [RESERVED] 1270 1270.1 to 1270.43 HUMAN TISSUE INTENDED FOR TRANSPLANTATION 1271 1271.1 to 1271.440 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS 1272-1299 [RESERVED]