Under the law, all mammography facilities must: 1) be accredited by an FDA-approved accreditation body, 2) be certified by FDA, or its State, as meeting the standards, 3) undergo an annual MQSA inspection, and 4) prominently display the certificate issued by the agency.In a nationwide survey of mammography facilities conducted in 1985, called Nationwide Evaluation of X-ray Trends (NEXT), the U.S. Food and Drug Administration found 36 percent to be producing mammographic images of unacceptable quality.

[2][3] Evidence from a 1990 General Accounting Office (GAO) study showed that many mammography providers lacked adequate quality assurance programs.

From June 20 to 22, 1990, NBC Nightly News correspondent Michelle Gillen presented a three-part series on the quality problems of mammography.

[3] In 1992, hearings held by the Senate Committee on Labor and Human Resources found numerous quality issues in the field of mammography.

The act became effective October 1, 1994, and requires all mammography facilities to meet quality standards as promulgated by the Food and Drug Administration (FDA).

[7] Costs of meeting the interim regulations, including staff training, equipment upgrades, enhancement of quality assurance programs, and improved notification of examination results to patients, was estimated to be $24 million annually.