Zdrowie i gospodarka · 31/10/2003

FDA Classifies Endotoxin Assay as Class II Device with Special Controls

The FDA has classified the endotoxin assay as a Class II device with special controls, following a petition submitted under the Federal Food, Drug, and Cosmetic Act, in response to the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002.