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 and Supplement for Digital Breast Tomosynthesis Mammography Systems

This alternative standard was approved and became effective on July 13, 2018. It has no time limit. Alternative Standard #24 was amended to allow for the use by mammography facilities of the Supplement for Digital Breast Tomosynthesis portion 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 which amends and replaces the previous Alternative Standard #24 is:

900.12(e)(6): Quality control tests--other modalities. For full-field digital mammography and digital breast tomosynthesis systems, the quality assurance program shall be substantially the same as the quality assurance program recommended by the ACR Digital Mammography Quality Control Manual and Supplement for Digital Breast Tomosynthesis (or such a manual that incorporates the Supplement and may be known by a different name but is unchanged in content) 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.

Please visit the ACR Mammography Accreditation website at http://www.acraccreditation.org/Modalities/Mammography for the latest information.

Page Last Updated: 07/20/2018
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