What is Mammography Quality Standards Act? (MQSA)

MQSA, or Mammography Quality Standards Act, is a federal act enacted by the U.S Congress in 1994. The purpose of the law is to set and enforce regulatory standards ensuring that all facilities performing mammography adhere to consistent high quality standards of practice. 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. Currently the ACR, or American College of Radiology only nationally-approved accreditation body.

The MQSA sets standards for both the safety and functionality of the mammography equipment as well as the performance of technologists and radiologists operating the equipment. There are also several provisions which directly impact on patients, such as requirements for providing patients with written results, addressing concerns, and obtaining original mammography films.

FDA Website