美国fda医疗器械中英文翻译（FDA medical devices in the United States）.doc

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美国fda医疗器械中英文翻译（FDA medical devices in the United States）.doc

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美国fda医疗器械中英文翻译（FDA medical devices in the United States） FDA medical devices in the United States 800 general rules GENERAL 801 identifies LABELING 803 medical device report MEDICAL DEVICE REPORTING 806 medical devices; correction and movement reports; MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS Registration of ESTABLISHMENT REGISTRATION AND LISTING AND INITIAL IMPORTERS OF DEVICES MANUFACTURERS DEVICE FOR EXEMPTIONS FROM FEDERAL STATE LOCAL MEDICAL DEVICE AND REQUIREMENTS (OF) PREEMPTION medical consultation for state and local medical device requirements 809 in vitro diagnostic products IN, VITRO, DIAGNOSTIC, PRODUCTS, FOR, HUMAN, USE 810 medical equipment recall right MEDICAL DEVICE RECALL AUTHORITY 812 test instruments exempt INVESTIGATIONAL, DEVICE, EXEMPTIONS 813 [reserved] [Reserved] 814 before the listing of medical devices approved PREMARKET APPROVAL OF MEDICAL DEVICES 820 quality system regulations QUALITY, SYSTEM, REGULATION 821 medical device tracking requires MEDICAL, DEVICE, TRACKING, REQUIREMENTS (only in the field of medical devices) 822 monitor POSTMARKET SURVEILLANCE after listing 860 medical device classification procedures MEDICAL, DEVICE, CLASSIFICATION, PROCEDURES 861 performance standards setting procedures PROCEDURES, FOR, PERFORMANCE, STANDARDS, DEVELOPMENT 862 clinical chemistry and clinical toxicology instruments CLINICAL, CHEMISTRY, AND, CLINICAL, TOXICOLOGY, DEVICES 864 hematology and pathology instruments HEMATOLOGY, AND, PATHOLOGY, DEVICES 866 immunology and microbiology instruments IMMUNOLOGY, AND, MICROBIOLOGY, DEVICES 868 ANESTHESIOLOGY DEVICES instruments of Anesthesiology 870 cardiovascular instruments CARDIOVASCULAR DEVICES 872 dental instruments DENTAL DEVICES 874 ear, nose, and pharynx instruments EAR, NOSE, AND, THROAT, DEVICES 876 - GASTROENTEROLOGY-UROLOGY DEVICES gastroenterology Urology Devices 878 general and orthopedic instruments GENERAL, AND, PLASTIC, SURGERY, DEVICES 880 general hospitals and individuals use