Medical Devices, Device Regulations, and Medical Device - CCTSI医疗器械，装置的规定，医疗设备cctsi.pptVIP

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2018-06-30 发布于浙江
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Medical Devices, Device Regulations, and Medical Device - CCTSI医疗器械，装置的规定，医疗设备cctsi.ppt

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Medical Devices, Device Regulations, and Medical Device - CCTSI医疗器械，装置的规定，医疗设备cctsi

Medical Devices, Device Regulations, and Medical Device Trials Presented by Catherine Parker, RN Consumer Safety Officer Division of Bioresearch Monitoring Office of Compliance Center for Devices and Radiological Health Objectives Define medical device Describe the classifications of devices Describe the ways a device can get to market Describe how medical device clinical trials differ from drug trials Medical Devices Medical Device Definition An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar article, including any component, part, or accessory which is: Recognized in the official National Formulary, or the United States pharmacopeia, or any supplement to them Intended for use in the diagnosis of disease or conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals Intended to affect the structure or any function of the body of man or other animals Which does NOT achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is NOT dependent upon being metabolized for the achievement of its intended purposes. The Important Points Device definition excludes products that: Achieve their primary intended purpose through chemical action within the body Are dependent upon being metabolized for the primary achievement of their primary intended purposes Medical Devices are Classified by Risk Class I Devices General controls are sufficient to provide reasonable assurance of the safety and effectiveness Examples: elastic bandages, examination gloves, and hand-held surgical instruments General Controls Prohibition against adulterated or misbranded devices Premarket notification 510(k) requirements Good Manufacturing Practices (GMPs) Labeling Registration of manufacturing facilities Listing of device types Record keeping Repair, replacement or refund Class II Devices . General controls alone are insufficient t