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Scope

The Code of Federal Regulations contains all Federal level regulations in one publication, published on an annual basis.

Abstract

CFR Title 21 - Food and Drugs: Parts 800 to 1299

800 General
801 Labeling
803 Medical device reporting
806 Medical devices; reports of corrections and removals
807 Establishment registration and device listing for manufacturers and initial importers of devices
808 Exemptions from federal preemption of state and local medical device requirements
809 In vitro diagnostic products for human use
810 Medical device recall authority
812 Investigational device exemptions
814 Premarket approval of medical devices
820 Quality system regulation
821 Medical device tracking requirements
822 Postmarket surveillance
860 Medical device classification procedures
861 Procedures for performance standards development
862 Clinical chemistry and clinical toxicology devices
864 Hematology and pathology devices
866 Immunology and microbiology devices
868 Anesthesiology devices
870 Cardiovascular devices
872 Dental devices
874 Ear, nose, and throat devices
876 Gastroenterology-urology devices
878 General and plastic surgery devices
880 General hospital and personal use devices
882 Neurological devices
884 Obstetrical and gynecological devices
886 Ophthalmic devices
888 Orthopedic devices
890 Physical medicine devices
892 Radiology devices
895 Banned devices
898 Performance standard for electrode lead wires and patient cables
900 Mammography
1000 General
1002 Records and reports
1003 Notification of defects or failure to comply
1004 Repurchase, repairs, or replacement of electronic products
1005 Importation of electronic products
1010 Performance standards for electronic products: general
1020 Performance standards for ionizing radiation emitting products
1030 Performance standards for microwave and radio frequency emitting products
1040 Performance standards for light-emitting products
1050 Performance standards for sonic, infrasonic, and ultrasonic radiation-emitting products
1107 Establishment registration, product listing, and substantial equivalence reports
1140 Cigarettes and smokeless tobacco
1141 Cigarette package and advertising warnings-effective: 9/22/2012
1210 Regulations under the federal import milk act
1230 Regulations under the federal caustic poison act
1240 Control of communicable diseases
1250 Interstate conveyance sanitation
1270 Human tissue intended for transplantation
1271 Human cells, tissues, and cellular and tissue-based products

Notes

Claudia's Notes:
Title 21 Code of Federal Regulations - Food and Drug Administration Parts 800 - 1299 contains many of the essential regulations on Medical Devices.  Remember:  It is an annual publication, revised each April.  The PDF edition is available usually within the month of April -- The print edition can take months to be released from the publishers.

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