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Title 21 Chapter I Subchapter H

Title 21 → Chapter I → Subchapter H

Electronic Code of Federal Regulations e-CFR

Title 21 Chapter I Subchapter H

Title 21Chapter ISubchapter H


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

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PartTable of
Contents
Headings
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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
IMMUNOLOGY AND MICROBIOLOGY DEVICES
868
868.1 to 868.6885
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
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SUBCHAPTER I—MAMMOGRAPHY QUALITY STANDARDS ACT

900
900.1 to 900.25
MAMMOGRAPHY
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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
1030.10
PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS
1040
1040.10 to 1040.30
PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
1050
1050.10
PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS
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SUBCHAPTER K—TOBACCO PRODUCTS

1100
1100.1 to 1100.5
TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY
1105
1105.10
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
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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]