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  Medical Device FDA - related regulations

edical Device FDA - related regulations
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The classification of medical devices is specified in Section 21 Food and Drugs of CFR (CODE OF FEDAL REGULATION).
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Rule number
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21CFR800 General
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21CFR801 label
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21CFR803 Medical Device Bulletin
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21CFR806 medical device calibration, maintenance report
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21CFR807 medical device manufacturers and initial importers registration and equipment list
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21CFR808 is exempt from the federal government's priority to purchase state and local medical equipment requirements
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21CFR809 human products for use in glass tubes.
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21CFR810 call for medical equipment
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21CFR812 Exemption for research equipment
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21CFR813 Reserved
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21CFR814 Pre-market approval of medical devices
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21CFR820 Quality rules for the production of medical devices
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21CFR821 medical device tracking requirements
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21CFR860 medical device classification procedures
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21CFR861 The development of performance standards for the use of medical devices
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21CFR862 Clinical Chemistry and Toxicology Instruments
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21CFR864 Hematology and Pathology Instruments
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Immunology and Microbiology Instruments
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21CFR868 Anesthesia equipment
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21CFR870 cardiovascular equipment
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21CFR872 dental instruments
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21CFR874 ENT equipment
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21CFR876 gastrointestinal - urological instruments
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21CFR878 ordinary plastic surgical instruments
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21CFR880 general hospital and personal equipment
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21CFR882 Neurological Instruments
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Obstetrics and Gynecology and Gynecology
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21CFR886 ophthalmic instruments
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21CFR888 orthopedic instruments
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21CFR 890 physical therapy equipment
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Radiation apparatus
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21CFR 895 ligation equipment
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21CFR 898 Performance standards for wire and cable for medical devices

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