FDA approves alternative mammography quality assurance program
An alternative digital full-field mammography quality assurance program has been cleared for use nationwide, according to an announcement from the FDA. The approval paves the way for the method to be deployed in U.S. healthcare facilities in place of device-specific program from manufacturers.
This new alternative standard, based on the American College of Radiology Digital Mammography Quality Control Manual, was found to meet the requirement of being “at least as effective in assuring quality mammography” as following the manufacturers’ quality control manuals.
The alternative method has been approved for use in all healthcare facilities with the requisite imaging systems.
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