July 23, 2018

FDA Approves New DBT Quality Control Tests for ACR Digital Mammography QC Manual

The Food and Drug Administration (FDA) approved the American College of Radiology’s (ACR’s) amendment to the 2016 Alternative Standard #24 to the “Quality control tests--other modalities” requirement. This FDA review and approval of the ACR Digital Breast Tomosynthesis (DBT) quality control (QC) test procedures enables the College to incorporate DBT into the 2016 ACR Digital Mammography Quality Control Manual.

The FDA requires digital mammography facilities with DBT to perform QC for approved imaging systems, according to their respective manufacturers’ quality control manuals. Approval of this amendment will enable mammography QC technologists and medical physicists to use the updated ACR manual in lieu of manufacturers’ quality control manuals when it becomes available.

“The new DBT QC procedures in the updated ACR manual will promote uniformity of quality control since it will allow facilities to follow one manual, instead of the dozens of different manuals that are mandated for the varying manufacturers and models of digital mammography equipment with DBT,” said Eric Berns, Ph.D., lead author and chair of the ACR Subcommittee on Mammography Quality Assurance. “The new manual focuses on tests that are clinically relevant for high-quality imaging and provides the structure for a thorough and complete quality control program.”

The updated manual is currently undergoing preparation for publication and should be available in the fall of 2018. ACR-accredited mammography facilities (and those applying for accreditation) will be invited to download a free PDF of the manual. Medical physicists associated with ACR-accredited facilities may also obtain the link to the manual from their facility to download a free version.

More information on the manual will be posted on the ACR Digital Mammography QC Manual Resources website as it becomes available. View the amended FDA alternative standard approval.