FDA: ACR may include DBT in quality control manual

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The U.S. Food and Drug Administration (FDA) has allowed the American College of Radiology (ACR) to incorporate digital breast tomosynthesis (DBT) quality control (QC) test procedures into the ACR Digital Mammography Quality Control Manual.

This came about via the FDA's approval of the ACR's amendment to the 2016 Alternative Standard No. 24 to the "Quality control tests -- other modalities" requirement.

The governmental body requires digital mammography facilities with DBT to perform QC for approved imaging systems according to their respective manufacturers' quality control manuals. Approval of the ACR's 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, according to the ACR.

The move will promote uniformity of quality control and provides the structure for a thorough and complete quality control program, the ACR added.

The updated manual is being prepared for publication and should be available in the fall of 2018. More information on the manual will be posted by the ACR as it becomes available.

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