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The Regulation of Medical Software under the Food, Drug and Cosmetic Act: A Perspective from the Government

FDA is currently developing a policy regarding application of the Food, Drug and Cosmetic Act in the medical software marketplace. It should be available for review in draft form in summer or early fall 1986. This paper reviews the Agency's device regulation program and its implications for any...

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Autor principal: Schneider, R.H.
Formato: Artigo
Idioma:Inglês
Publicado em: 1986
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC2244976/
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