FDA Approves the ACR To Accredit Lorad Selenia FFDM Units - 10/31/2003
On Sept. 4, 2003, the Food and Drug Administration approved the American College of Radiology (ACR) to accredit Lorad Selenia full-field digital mammography (FFDM) units beginning Sept. 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 Lorad Selenia 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. As of Sept. 15, 2003, the FDA will no longer accept applications to extend existing MQSA certificates to include the use of Lorad Selenia FFDM units. As of that date, all new applicants with these types of Lorad units must contact the ACR and apply for the accreditation of these units. Applicants with FFDM units other than the GE Senographe 2000D, the Fischer SenoScan or the Lorad Selenia must continue to apply to and be approved by the 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.