FDA Approves the ACR to Accredit GE Senographe 2000D Full-Field Digital Mammography Units - 10/31/2003
On Dec. 18, 2002, the Food and Drug Administration (FDA) approved the American College of Radiology (ACR) to accredit GE Senographe 2000D full-field digital mammography (FFDM) units beginning Feb. 15, 2003. On that date, the ACR will begin contacting facilities that have already received FDA approval extending their MQSA certificate to include the use of a GE Senographe FFDM unit to advise them of the steps to take to achieve accreditation of these units. Such facilities need not take any action towards accreditation until they are contacted by the ACR, and can continue to operate during the transitional period. More information will be available on the ACR Web site after the first of the year.
As of Feb. 15, 2003, the FDA will no longer accept applications to extend existing MQSA certificates to include the use of GE Senographe 2000D FFDM units. As of that date, all new applicants with these types of GE units must contact the ACR and apply for the accreditation of these units. Applicants with FFDM units other than the GE Senographe 2000D must continue to apply to and be approved by FDA for extension of their certificate to include the use of an FFDM unit, in order to legally operate those digital units.
If you have any questions, please contact the ACR at (800) 227-6440.