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BME_416_Device_Classification_Feb_6_2009_97_2003

BME_416_Device_Classification_Feb_6_2009_97_2003 - Michael...

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Michael Jamieson Regulatory Science Program USC School of Pharmacy February 6, 2009
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“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science- based information they need to use medicines and foods to improve their health.”
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An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part, or accessory, which is: i a/ recognized in the official national formulary, or US Pharmacopeia, or any supplement to them; i b/ intended for use in the diagnosis, treatment or prevention of disease, in man or other animals; or
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(a) c/intended to affect the structure or function of the body of man or other animals, AND 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 primary intended purposes.
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Submission of device information prior to marketing (510k or PMA or PDP) Device classification by risk (Class I, II, III) Establishment registration and device listing Labeling requirements & restrictions Manufacturing requirements (QSR-GMPs) Facility inspections Standards and guidance documents for devices & materials
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The basic framework governing the regulation of medical devices is established in the Medical Device Amendments to the Federal Food, Drug, and Cosmetic (FFD&C) Act. The Medical Device Amendments were enacted on May 28, 1976. The FFD&C Act was again amended with respect to the regulation of medical devices by the Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992.
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New provisions governing the export of FDA regulated products, including medical devices, were established in the FDA Export Reform and Enhancement Act of 1996. The FFD&C Act was most recently amended by the Food and Drug Administration Modernization Act of 1997 (the Modernization Act).
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The CFR is a codification of the general and permanent rules that were published in the FR by the Executive departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. These final regulations codified in the CFR cover various aspects of design, clinical evaluation, manufacturing, packaging, labeling and post market surveillance of medical devices. In addition, the regulations address standards and product reports that apply to radiation-emitting products.
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Parts 1 - 99 (product jurisdictions, protection of human subjects, institutional review boards, etc) i Parts 100 - 799 (food, human and animal drugs, biologics, cosmetics) i Parts 800 - 1299
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