Mod6_pt2_MD_Submissions - 11/30/2009 Medical Devices Types...

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11/30/2009 1 Medical Devices Types of Submissions and Overview of Regulations PHAR 6010 FDA Mission 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. 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. 2 FDA Authority to Regulate • Medical Device Amendments May 28, 1976 3 • Regulations implementing FD&C Act Title 21 Code of Federal Regulations (21CFR) Parts 800 - 1299
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11/30/2009 2 Definition of a Drug (a) Articles recognized in the official UA Pharmacopoeia, official Homeopathic Pharmacopoeia of the US or official National Formulary, or any supplement to them; (b) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; (c) articles (other than food) intended to affect the structure or function of the body of man or other animals; or (d) articles intended for use as a component of any article specified in clauses (a), (b) or (c). 4 Definition of a Device FD&C Act of 1938: Device • An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any component, part, or accessory, which is (a) recognized in the official National Formulary, or US Pharmacopoeia or any supplement to them; (b) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of a disease, in man or other animals; (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 purposes. 5 Definition of a Cosmetic • (a) Articles intended to be rubbed, poured, sprinkled, sprayed on, introduced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; and • (b) articles intended for use as a component of any such article, except that such shall not include soap. 6
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11/30/2009 3 Key Milestones for Devices 1938 The Federal Food, Drug and Cosmetic Act (therapeutic devices) 1966 Fair Packaging and Labeling Act (Honest and informatively labeled) 1976 Medical Device Amendments 1978 Good Manufacturing Practices 1981 Investigational Device Exemptions 1984 Medical Device Reporting 1985
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This note was uploaded on 01/01/2012 for the course PHAR 6010 taught by Professor Mullis during the Spring '11 term at University of Georgia Athens.

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Mod6_pt2_MD_Submissions - 11/30/2009 Medical Devices Types...

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