On Oct. 27, 1992, the Mammography Quality Standards Act (MQSA) was passed (P.L. 102-539) by the U.S. Congress and signed into law by President George H.W. Bush.

MQSA required the Department of Health and Human Services (HHS) to develop standards that would be enforced through strict accreditation, certification and inspection, of equipment and personnel at mammography facilities.

MQSA is intended to ensure that all women have access to safe and effective mammography services for early detection of breast cancer. All U.S. mammography facilities, except those managed by the Department of Veterans Affairs, must be certified by the Food and Drug Administration (FDA) to legally continue to provide mammography services.

The FDA was delegated the authority to implement MQSA in June 1993. On December 21, 1993, the FDA published interim standards in the Federal Register covering equipment, personnel, quality assurance, and record keeping and reporting.

The interim standards also set requirements that must be met by accrediting bodies. FDA is collaborating with the National Mammography Quality Assurance Advisory Committee to develop more comprehensive, final standards.