The U.S. Food and Drug Administration (FDA) has approved the American College of Radiology (ACR) to accredit Carestream Health's DirectView full-field digital mammography (FFDM) system beginning February 16, 2011.
The ACR plans to begin contacting facilities that use Carestream systems under an FDA-approved extended Mammography Quality Standards Act (MQSA) certificate to advise them of this change and how to proceed with accreditation. Such facilities need not take any action toward accreditation until they are contacted by the ACR, and they are permitted to operate during the transition period, according to Reston, VA-based ACR.
Beginning February 16, the FDA will no longer accept applications to extend existing MQSA certificates to include the use of Carestream DirectView FFDM systems. As of that date, facilities should contact the ACR for information on how to begin the accreditation process, the ACR said.
