News | Quality Assurance (QA) | March 08, 2016

FDA Approves Alternative Quality Assurance Standard for Full Field Digital Mammography

Alternative standard based on ACR Digital Mammography Quality Control Manual

FDA, alternative standard, full field digital mammography, FFDM, qualtity assurance QA

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

Related Content

SmartCurve technology, a revolutionary breast imaging technology designed specifically for the curvature of the female breast to provide every woman with a more comfortable and accurate mammogram.
News | Mammography | September 14, 2018
Solis Mammography declared September Breast Wellness Month a
breast screening
News | Clinical Trials | September 13, 2018
Fewer and fewer women die from breast cancer in recent years but, surprisingly, the decline is just as large in the a
Lightvision near-infrared fluorescence imaging system
News | Women's Health | September 11, 2018
Shimadzu Corp.
Feature | Breast Imaging | September 07, 2018 | By JoAnn Pushkin
If you are confused about the conflicting advice surrounding mammography screening guidelines, welcome to the club.
Illinois Governor Approves State Breast Density Reporting Bill Into Law
News | Breast Density | August 13, 2018
Illinois Gov. Bruce Rauner approved the Illinois Breast Density Reporting Law (Public Act 100-0749) on Aug. 10, 2018...
PET Tracer Identifies Estrogen Receptor Expression Differences in Breast Cancer Patients
News | PET Imaging | August 09, 2018
In metastatic breast cancer, prognosis and treatment is largely influenced by estrogen receptor (ER) expression of the...
iCAD Receives FDA Clearance of PowerLook Density Assessment for Digital Breast Tomosynthesis
Technology | Breast Density | August 08, 2018
iCAD announced U.S. Food and Drug Administration (FDA) clearance of its latest artificial intelligence (AI) software...
Cardiac Imaging Reveals Roots of Preeclampsia Damage in Pregnant Women
News | Women's Health | August 07, 2018
Johns Hopkins researchers say a heart imaging study of scores of pregnant women with the most severe and dangerous form...
Cardiac Monitoring a Higher Priority for High-Risk Breast Cancer Patients
News | Cardio-oncology | August 07, 2018
August 7, 2018 — While heart failure is an uncommon complication of...