Devices

CDRH OKs Alternative Standard for Mammography Systems

CDRH has approved an alternative standard for using a quality assurance program recommended by the ACR Digital Mammography Quality Control Manual for full-field digital mammography systems. An agency notice says the alternative standard was approved and became effective 2/17, and it can be used by mammography facilities instead of the quality assurance program recommended by image receptor manufacturers. 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)(5)(vi), which states:

900.12(e)(5)(vi): 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)(5)(vi): 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.

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