Radiation-Emitting Products

#24: Approval of an Alternative Standard for Using the Quality Assurance Program Recommended by the ACR Digital Mammography Quality Control Manual for Full-Field Digital Mammography Systems, for Systems without Advanced Imaging Capabilities

This alternative standard was approved and became effective on February 17, 2016. It has no time limit. The alternative standard allows for the use by mammography facilities of the ACR Digital Mammography Quality Control Manual as an alternative to the quality assurance program recommended by the image receptor manufacturer. The FDA has determined that the ACR's quality control manual is, as required in § 900.18(a)(1): Alternative Requirements, “at least as effective in assuring quality mammography” as following the manufacturers’ QC manuals.

The original standard is 21 CFR 900.12(e)(6), which states:

900.12(e)(6): Quality control tests--other modalities. For systems with image receptor modalities other than screen-film, the quality assurance program shall be substantially the same as the quality assurance program recommended by the image receptor manufacturer, except that the maximum allowable dose shall not exceed the maximum allowable dose for screen-film systems in paragraph (e)(5)(vi) of this section.

The approved alternative is:

900.12(e)(6): Quality control tests--other modalities. For full-field digital mammography systems without advanced imaging capabilities, the quality assurance program shall be substantially the same as the quality assurance program recommended by the ACR Digital Mammography Quality Control Manual when used with the ACR Digital Mammography Phantom, except that the maximum allowable dose shall not exceed the maximum allowable dose for screen-film systems in paragraph (e)(5)(vi) of this section.

Any facility may avail itself of the approved alternative standard for the described imaging systems.

Note: At this time, the new ACR Digital Mammography Quality Control Manual and accompanying phantom are not available for facility use. More information will be available in the near future. Please visit the ACR Mammography Accreditation website at http://www.acraccreditation.org/Modalities/Mammography for the latest information
 

Page Last Updated: 03/10/2016
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