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Validation of Medical Software: Present Policy of the Food and Drug Administration

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Rockville, Maryland

© 1987 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1987;106(4):628-629. doi:10.7326/0003-4819-106-4-628
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As the introduction of information management into the realm of medical devices takes place, the computer revolution markedly affects the regulatory responsibility of the Food and Drug Administration (FDA). According to the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act passed on 28 May 1976 (Public Law 94-295), a device is defined as ". . . an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or other similar or related article, including any part of accessory which is . . . intended for use in the diagnosis of disease or other conditions or in the cure,


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