This document is intended to provide guidance to industry on the type of information needed by the Center for Devices and Radiological Health (CDRH) to evaluate a marketing application for a full-field digital mammographic (FFDM) system. It supersedes Information for Manufacturers Seeking Marketing Clearance of Digital Mammography Systems: Status Update, issued February 4, 1999.
Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA
Feb 15, 2001
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