Food and Drug Administration Modernization Act of 1997; List of Documents Issued by the Food and Drug Administration That Apply to Medical Devices Regulated by the Center for Biologics Evaluation and Research

概要

The Food and Drug Administration (FDA) is publishing a list of documents issued in response to the Food and Drug Administration Modernization Act of 1997 (FDAMA), and clarifying their applicability to medical devices regulated by the Center for Biologics Evaluation and Research (CBER). This notice is intended to inform the public of the availability of these documents, clarify their scope of applicability, and to provide instructions on ways to access them.