FDA OKs ACR's digital mammo manual

The U.S. Food and Drug Administration (FDA) has approved the American College of Radiology's (ACR) alternative standard request for use of the new Digital Mammography Quality Control (QC) Manual and Digital Mammography QC Phantom in routine QC of digital equipment.

The FDA requires that all digital mammography facilities perform quality control for approved imaging systems according to manufacturers' manuals. The approval of this alternative standard will enable mammography QC technologists and medical physicists to use the new ACR manual in lieu of manufacturers' quality control manuals.

The FDA alternative standard specifies that the new manual may only be used for full-field digital mammography systems without advanced imaging capabilities, such as tomosynthesis or contrast enhancement.

The manual currently is undergoing preparation for publication and should be available this spring.

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