April 04, 2018

FDA Approves ACR to Accredit FDA-approved DBT Units

The Food and Drug Administration (FDA) has approved the American College of Radiology (ACR) to accredit all FDA-approved Digital Breast Tomosynthesis (DBT) units beginning April 9, 2018.

The ACR will begin contacting facilities which already use the DBT systems under an FDA-approved extended MQSA certificate to advise them of this change and how to proceed with accreditation. Such facilities need not take any action towards accreditation until they are contacted by the ACR, and are permitted to operate during the transition period.

Beginning April 6, 2018, the FDA will no longer accept applications to extend existing MQSA certificates to include the use of all approved DBT systems. As of that date, facilities should contact the ACR for information on how to begin the accreditation process.
The following systems must be accredited:

  • Fujifilm ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option
  • GE Senographe Pristina with Digital Breast Tomosynthesis (DBT) Option
  • GE SenoClaire Digital Breast Tomosynthesis (DBT) System
  • Hologic Selenia Dimensions Digital Breast Tomosynthesis (DBT) System
  • Siemens MAMMOMAT Inspiration with Digital Breast Tomosynthesis (DBT) Option

For more information, please see the Mammography Frequently Asked Questions or contact the ACR at (800) 227-6440.