Mammography is the most effective noninvasive means available for examining the breast. It is the most sensitive and accurate method known for detecting acute breast cancer.
On December 21, 1993, the Food and Drug Administration (FDA) published interim regulations for mammography facilities and accreditation bodies. Developement of the final regulations began with the first meeting of the National Mammography Quality Assurance Advisory Committee in February 1994. Proposed rules were published on April 3, 1996. On October 28, 1997, the FDA issued the more comprehensive final regulations which became effective on April 28, 1999.
Since 1994, FDA has provided guidance documents designed to help facilities comply with the regulations. These documents can be found on the Radiation-Emitting Products section of the FDA website. The FDA continues to update its guidance regularly and a facility can join the FDA's listserver to get notifications of mammography updates.
Under the Mammography Quality Standards Act (MQSA), facilities may be inspected by FDA inspectors, state or local agency inspectors under FDA contract. Only the FDA performs annual inspections of federal facilities. The State of Alabama Office of Radiation Control has the FDA-qualified MQSA inspectors who meet specific qualifications and who must maintain these qualification by meeting continuing education and experience requirements. Inspectors have received specialized training in radiation physics, physics related to mammography equipment, and inspecting mammography facilities compliance with MQSA regulations. Contact state inspectors by emailing the Office of Radiation Control.
- Medical Physicist Involvement in Equipment Adjustments, Changes, or Repairs
- Newly Installed or Reassembled Processor
- Operating and Safety Procedures for Mammography
- Mammography Inspection Checklist
- National Cancer Institute's Breast Cancer Risk Assessment Tool
- Breast Cancer Treatment Education Act of 2013 (Act 2013-284)
Page last updated: April 12, 2017