Digital Breast Tomosynthesis (DBT) System

MQSA Facility Certification Extension Requirements for Digital Breast Tomosynthesis (DBT) System

NOTE 1: Under MQSA, each manufacturer’s Digital Breast Tomosynthesis system is currently considered a separate new mammographic modality, and the personnel requirements for new modality training apply.

NOTE 2: In order to use the tomosynthesis portion of the unit, the facility must apply to FDA to have its certificate extended to include that portion of the unit. The certification extension only applies to the DBT portion of the unit. The facility must have the 2D portion of the unit accredited by one of the accreditation bodies already approved to accredit the 2D portion.

The MQSA Certificate Extension Program DBT System requirements have been updated and are available athttp://www.fda.gov/Radiation-EmittingProducts/MammographyQualityStandardsActandProgram/FacilityCertificationandInspection/ucm413117.htm