FDA Approves Alternative Quality Assurance Standard for Full Field Digital Mammography

March 8, 2016 — The U.S. Food and Drug Administration (FDA) announced the approval of an alternative digital mammography quality assurance (QA) program that mammography facilities may use instead of the program recommended by the image receptor manufacturer. The alternative standard is based on the American College of Radiology (ACR) Digital Mammography Quality Control Manual.

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.

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

For more information: www.fda.gov