Manufacture of in Vitro Diagnostic Products; Current Good Manufacturing Practice Final Guideline; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a final guideline entitled ``Guideline for the Manufacture of In Vitro Diagnostic Products'' that contains production practices which are acceptable to FDA for assuring the safety and effectiveness of in vitro diagnostic products. Manufacturers of in vitro diagnostic products may find the information in the guideline useful in developing procedures that comply with the current good manufacturing practice (CGMP) regulations for these products. A draft document was previously made available for public comment.