Note to MAMMOGRAPHY FACILITY STAFF: If you have questions about the MQSA Program, please call the MQSA Facility Hotline at 1-800-838-7715 or email your questions to [email protected]

Effective April 9, 2018, all FDA MQSA accreditation bodies (AB) are approved to accredit DBT mammography systems. After April 6, 2018, the FDA's certificate extension program will no longer be accepting applications to approve the use of DBT based on a facility's existing FFDM accreditation. That means all facilities must now have their existing and future DBT units accredited by their AB. All MQSA certificate extensions for the use of DBT units that have been granted to date will remain in effect until the AB and the facility complete the transition of those DBT units to their AB's accreditation program. Contact information for the each AB can be found on our Accreditation Bodies page. Any applications received by the FDA after April 6, 2018, will be returned to the facility.

Please contact your AB for information on the types of images it accepts for accreditation as well as on how to submit images.

For answers to commonly asked questions regarding new modality training for personnel prior to using DBT systems, please see our page Frequently Asked Questions about DBT and MQSA.

The primary purpose of the FDA's certificate extension program has always been to provide a temporary way for new technology to be available to benefit patients when ABs did not have standards developed, or the processes in place, to accredit a new mammography technology. This is the pathway that was taken when FFDM first entered the market, and more recently, when DBT first entered the market. Once an AB is ready to accredit the new mammography technology, applies to FDA for approval to accredit, and is approved to do so, the transition from the certificate extension program to the AB occurs, as accreditation is mandated by the MQSA. FDA works closely with the ABs to assist facilities with this transition; however, individual ABs can establish their own accreditation procedures within the confines of the MQSA requirements for accreditation.

DBT Systems

Below is a list of DBT units approved by FDA for marketing, with their respective dates of market approval:

• GE Senographe Pristina with Digital Breast Tomosynthesis (DBT) Option - 03/3/2017
• Fujifilm ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option - 01/10/2017
• Siemens MAMMOMAT Inspiration with Digital Breast Tomosynthesis (DBT) Option - 04/21/2015
• GE SenoClaire Digital Breast Tomosynthesis (DBT) System - 08/26/2014
• Hologic Selenia Dimensions Digital Breast Tomosynthesis (DBT) System - 02/11/2011