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The Regulation of Medical Computer Software as a “Device” under the Food, Drug, and Cosmetic Act
Recent developments in computer software have raised the possibility that federal regulators may claim to control medical computer software as a “device” under the Food, Drug and Cosmetic Act. The purpose of this paper is to analyze the FDCA to determine whether computer software is included in the...
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| Formato: | Artigo |
| Lenguaje: | Inglês |
| Publicado: |
1986
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| Materias: | |
| Acceso en línea: | https://ncbi.nlm.nih.gov/pmc/articles/PMC2244973/ |
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