The U.S. Food and Drug Administration (FDA) has approved the American College of Radiology (ACR) of Reston, VA, to accredit the FCRm computed radiography mammography system from Fujifilm Medical Systems USA.
Many facilities have been using the FCRm system under an FDA-approved extended certificate in the Mammography Quality Standards Act (MQSA) program. The ACR will begin contacting these facilities to advise them of the change and how to proceed with accreditation, according to the Stamford, CT, company. Such facilities do not need to take any action until they are contacted by the ACR, and are permitted to operate during the transition period.
Starting on November 15, the FDA no longer accepted applications to extend existing MQSA certificates to include the use of Fuji FCRm systems, and those systems should be accredited, the company said.
By AuntMinnie.com staff writers
November 15, 2006
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