Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA

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.

http://www.fda.gov/cdrh/ode/guidance/983.html