For questions regarding this document contact Mary Pastel (OIVD) at 301-796-6887 or by e-mail at or Kyle J. Myers (OSEL) at 301-796-2533 or by e-mail at

This document supersedes “Class II Special Controls Guidance Document: Full-Field Digital Mammography System,” issued November 5, 2010.



U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division of Imaging and Applied Mathematics

Office of Science and Engineering Laboratories (OSEL)


The purpose of this evaluation is to determine if the FFDM images, when reviewed by expert radiologists, are judged to be of sufficiently acceptable quality for mammographic usage that they are substantially equivalent in safety and effectiveness to those from a predicate device. If the physical laboratory testing comparison shows the new device to be substantially equivalent in safety and effectiveness to the laboratory performance of the predicate device, for all characteristics, you should submit the following image evaluation.