Large multicenter studies demonstrate that Digital Breast Tomosynthesis reduces call back and increases breast cancer detection. The MQSA and FDA require documented training in Digital Breast Tomosynthesis prior to independent use in clinical practice. (2, 3)
FDA/MQSA UPDATE: January 1, 2017
Question: Is digital breast tomosynthesis (DBT) a mammographic modality under MQSA?
Answer: “While there are technological differences between these DBT systems, and differences in their FDA-approved Indications for Use, these systems are now treated under MQSA, like full field digital mammography units, as a single mammographic modality. Facilities that perform mammography using any of these DBT units are subject to MQSA requirements.”
|MQSA DBT Mammographic Modality(s)||Training Resources||Hours and Credits||Formats||MQSA Manufacture Modality Specific Training Topics Syllabi|
|All Manufactures||“Breast Tomosynthesis 3D Mammography” 8.75 Hours Tomosynthesis Training
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|8.75 AMA PRA Category I Credits™ for the MQSA Digital Breast Tomosynthesis general topic DBT initial training and FDA/MQSA CME requirement.||Video on Demand and or DVD with Syllabus|
This January 2017 guidance supersedes:
FDA/MQSA UPDATE MAY 22, 2015
Question: What documentation should MQSA inspectors look for in order to determine that a facility is in compliance with new mammographic modality training? (1)
Answer: 8 hours of training in general DBT topics.
Question: Must the training be provided by the manufacturer?
Answer: No. Under MQSA, the new modality training, including the training on the unique features (the technological differences and the IFU) of a particular DBT system, does not need to be provided by the manufacturer.”….(1)
*Interpreting Physician New Mammographic Modality Training
900.12(a)(1)(ii)(C): Before an interpreting physician may begin independently interpreting mammograms produced by a new mammographic modality, that is, a mammographic modality in which the physician has not previously been trained, the interpreting physician shall have at least 8 hours of training in the new mammographic modality.
In addition to Digital Breast Tomosynthesis (DBT) CME and DBT training, it is recommended that every physician new to DBT participate in hands-on training prior to independent clinical interpretation.
For further information, check:
FDA Links and Other Information: