FDA Approves the ACR to Accredit FDA-Approved DBT Units

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By Theresa Branham, BSRS

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

According to Jacqueline A. Bello, MD, FACR, chair of the American College of Radiology Commission on Quality and Safety, “Nearly half of all mammography facilities in the United States now offer DBT. It is vital that these units be accredited like other breast imaging modalities in order to deliver on their important promise to improve care. We are proud that the FDA has approved the ACR to ensure that women have access to the best possible breast imaging care — including DBT.”

You may be wondering what this change will mean for your facility.

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

Facilities that have already received an FDA extension of their MQSA certificate for their DBT units will renew DBT accreditation with the ACR instead of the FDA at their usual time of renewal.

As of April 6, 2018, the FDA no longer accepts applications to extend existing MQSA certificates to include the use of approved DBT systems. Facilities should contact the ACR for information on how to begin the accreditation process.

The following DBT 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 visit the ACR Mammography Accreditation webpage, or contact the ACR at (800) 227-6440.

Theresa Branham, BSRS, is the director, ACR Breast Imaging Accreditation. She can be reached at tbranham@acr.org.

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