FDA posts guidance on MQSA regulation of DBT units

The U.S. Food and Drug Administration (FDA) has posted a frequently asked questions page on its website regarding digital breast tomosynthesis (DBT) and Mammography Quality Standards Act (MQSA) training requirements.

The page addresses questions such as whether DBT is a mammographic modality under MQSA, how the MQSA "new modality" training requirements apply to DBT, and the status of training received prior to FDA's approval of DBT systems from GE Healthcare and Siemens Healthcare.