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lecture_7 - Overview of the FDA Regulation of the Medical...

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Unformatted text preview: Overview of the FDA Regulation of the Medical Device Industry S. Laguette ME128 Fall 2007 October 22, 2007 10/22/07 ME128 Overview of the FDA History of the FDA Federal Food, Drug, and Cosmetic Act of 1976 Registration and Listing Classification of Devices Regulatory Approval Process 10/22/07 ME128 History of the FDA The US Food and Drug Administration (FDA) is a scientific, regulatory and public health agency. Its jurisdiction includes most food products, human and animal drugs, therapeutic agents of biologic origin, medical devices, radiation-emitting products, and animal feed 10/22/07 ME128 History of the FDA The agency has grown from a single chemist in 1862 to over 9,000 employees and a budget of $2.1 billion proposed for 2008. The FDA monitors the manufacture, import, transport, storage, and sale of about $1 trillion worth of products at an annual cost of about $3 per taxpayer 10/22/07 ME128 FDA History 1906 FDA formed, banned interstate commerce in adulterated misbranded food, drink, and drugs 1938 Federal Food, Drug and Cosmetic Act 10/22/07 ME128 FDA Act 1938 requiring that new drugs be shown to be safe before marketing. extending FDA's control to cosmetics and therapeutic devices. authorizing factory inspections and standards of identity for food staples. eliminating a requirement to prove intent to defraud in drug misbranding cases. adding court injunctions to the previous penalties of seizures and prosecutions 10/22/07 ME128 FDA History Continued 1962 sale/use of thalidomide banned in U.S. based upon thousands of birth defects, primarily in Europe & South America amendment for efficacy & safety 1969 hearings re injuries (10,000) & deaths (731) in a 10 year period [heart valves, pacemakers, IUDs, ... (Nader)] 10/22/07 ME128 FDA History Continued 1976 Medical Device Amendments [new=> review, old=>grandfathered, new equivalent=>grandfathered] 1978 Good Manufacturing Practices 1984 Medical Device Reporting 1988 Device Recall/Rebuild 1990 Safe Medical Devices 10/22/07 ME128 A medical device is:"an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: - recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, - intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or - intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's 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 any of its primary intended purposes." FDA Definition 10/22/07 ME128 Examples of medical devices regulated by CDRH total joint replacement wheelchair tooth crown artificial heart valve contact lens 10/22/07 syringe tongue depressor ME128 Examples of radiological devices CD/DVD players Airport luggage inspection devices TV monitors Fluorescent lights microwave laser pointer cell phone 10/22/07 ME128 Examples of radiation-emitting medical devices CT scanner Surgical laser Diagnostic ultrasound Mammography equipment MRI machine 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 10/22/07 ME128 FDA/CDRH website http://www.fda.gov/cdrh/devadvice/index.html http://www.fda.gov/cdrh/devadvice/313.html http://www.fda.gov/cdrh/devadvice/3132.html#class_ 1 http://www.fda.gov/cdrh/devadvice/3132.html#class2 http://www.fda.gov/cdrh/devadvice/3132.html#class2 http://www.fda.gov/cdrh/devadvice/3131.html#proce ed 10/22/07 ME128 ...
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