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Currently, a summary of a mammography center’s written report must be sent directly to the patient and must be written in terms easily understood by a layperson. This summary is sent as a result of the U.S. Food and Drug Administration’s (FDA) Mammography Quality Standards Act (MQSA). Right now, there is no federal law or regulation requiring that summary to include information about a patient’s breast density. To create a national standard so that all women receive notification of breast density, an MQSA amendment to the "lay" letter reporting requirement is needed.


Creating and enacting federal laws through the U.S. Congress is referred to as the “legislative” process, while creating and enacting regulations, which are equally enforceable, is generally referred to as the "rulemaking" process. Congress passes a law designed to address a social or economic need or problem. The appropriate regulatory agency then creates regulations necessary to implement the law.

An MQSA amendment can be accomplished either through federal legislation or federal regulation, and advocacy efforts have been initiated on both fronts.

Federal Legislation: The Breast Density and Mammography Reporting Act of 2015 was introduced into both the U.S. House of Representatives (H.R. 716) and U.S. Senate (S. 370) in the last Congress (which ended in 2016). The Act outlined that mammography reports include information about breast density and “convey the effect of breast density in masking the presence of breast cancer on mammography...” Many existing state breast density inform laws meet or surpass the scope of information in this proposed legislation. Unless federal requirements are more stringent than state laws, the state laws will continue to be effective. The Act has not yet been introduced in the current Congressional session which began in January 2017.

Federal Regulation: A national density inform standard could become law even if a bill does not progress through Congress through a regulatory amendment to the FDA’s MQSA. The FDA anticipates issuing a Breast Density Reporting amendment to the Mammography Quality Standards Act (MQSA) as a “Notice of Proposed Rulemaking.” The proposed language has not been made public to date.

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