FDA Approves Alternative Standard Breast Density Reporting

The FDA approved an ACR® request June 23, for an Alternative Standard (#26) that will allow the interpreting physician to provide an overall assessment of breast density with singular phrasing in reports of unilateral mammograms, effective immediately. The agency will provide more information in the future.  

“We are happy that the FDA approved ACR’s request for an alternative standard as this will allow interpreting physicians the opportunity to provide information that is clinically relevant to each individual patient,” said Stamatia V. Destounis, MD, FACR, Chair of ACR’s Commission on Breast Imaging.

The original standard is 21 CFR 900.12(c)(1)(vi), which states:

21 CFR 900.12(c) Medical records and mammography reports – (1) Contents and terminology…
(vi) Overall assessment of breast density, classified in one of the following categories:
(A) “The breasts are almost entirely fatty.”
(B) “There are scattered areas of fibroglandular density.”
(C) “The breasts are heterogeneously dense, which may obscure small masses.”
(D) “The breasts are extremely dense, which lowers the sensitivity of mammography.”…

(2) Communication of mammography results to the patients. …
(iii) If the mammography report identifies the patient’s breast density as “The breasts are almost entirely fatty” or “There are scattered areas of fibroglandular density,” the lay summary shall include the statement “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.

(iv) If the mammography report identifies the breast density as “The breasts are heterogeneously dense, which may obscure small masses” or “The breasts are extremely dense, which lowers the sensitivity of mammography,” the lay summary shall include the statement “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.”

The approved “Alternative Standard #26: Issuing a Report with a Breast Density Assessment that is Phrased in the Singular, or is Neither Singular Nor Plural” is as follows:

21 CFR 900.12(c) Medical records and mammography reports – (1) Contents and terminology…
(vi) Overall assessment of breast density, classified in one of the following categories:
(A) “The breast is almost entirely fatty.”
(B) “There are scattered areas of fibroglandular density.”
(C) “The breast is heterogeneously dense, which may obscure small masses.”
(D) “The breast is extremely dense, which lowers the sensitivity of mammography.”
(E) “Breast Density: Almost entirely fatty”
(F) “Breast Density: Scattered areas of fibroglandular density”
(G) “Breast Density: Heterogeneously dense, which may obscure small masses”
(H) “Breast Density: Extremely dense, which lowers the sensitivity of mammography”…

(2) Communication of mammography results to the patients. …
(iii) If the mammography report identifies the patient’s breast density as “The breast is almost entirely fatty,” “There are scattered areas of fibroglandular density,” “Breast Density: Almost entirely fatty,” or “Breast Density: Scattered areas of fibroglandular density,” the lay summary shall include the statement “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is not dense. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.”

(iv) If the mammography report identifies the breast density as “The breast is heterogeneously dense, which may obscure small masses,” “The breast is extremely dense, which lowers the sensitivity of mammography,” “Breast Density: Heterogeneously dense, which may obscure small masses,” or “Breast Density: Extremely dense, which lowers the sensitivity of mammography,” the lay summary shall include the statement “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.”

Visit ACR Mammography Accreditation for more information.

If you have questions, contact Pamela Platt, ACR Manager, Accreditation, Quality and Safety.