Regulatory issues.
The medical device amendments of 1976 to the Food, Drug and Cosmetic Act created three levels regulation for devices: Class 1, General Controls: meaning that only the general provisions of the Act would be needed by the FDA to control the safety and effectiveness of devices in this class. General co...
| Publicado en: | IEEE Engineering in medicine and biology magazine 23, 1 (2004). |
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| Autor Principal: | |
| Formato: | Artigo |
| Idioma: | English |
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