Who Regulates Mammography?
Congress enacted Mammography Quality Standards Act (MQSA) to ensure that all women have access to quality mammography for the detection of breast cancer in its earliest, most treatable stages. The Act was amended in 1998 and 2004 (MQSRA).
To assist the FDA with this task, the National Mammography Quality Assurance Advisory Committee was mandated by Congress. It has between 13 and 19 members who are physicians, practitioners, other health professionals, consumer and industry representatives. Their clinical practice, research specialization, or professional expertise includes a significant focus on mammography.
The Advisory Committee determined the rules for:
- Personnel : Physicians who interpret mammograms, radiologic technologists who perform mammography, and medical physicists who survey equipment must have adequate training and experience
- Quality Control/Record-keeping : Each facility must have an effective quality control program and maintain certain records
- Medical Audit : Each facility must have a system for following up on mammograms that reveal problems, and for obtaining biopsy results
Since its existence, the Committee has spurred mammography facilities to improve their services to meet the MQSA standards. Only a very few mammography facilities have had to close for failing to meet the standards.
Find a Certified Mammography Facility in Your Area:
Mammography Facilities : FDA Database
Learn More – Primary Sources:
About the FDA’s Mammography Program