FDA Mammography Quality Standards Act Final Regulations

The Mammography Quality Standards Act Final Guidance for Industry and the FDA, document #4, is intended to provide guidance to mammography facilities and their personnel. It represents the Food and Drug Administration's (FDA) current thinking on implementing the Mammography Quality Standards Act (MQSA) (Pub. L. 102-539).

The Mammography Quality Standards Act (MQSA) was passed on October 27, 1992, to establish national quality standards for mammography in the U.S. The MQSA required that to provide mammography services legally after October 1, 1994, all facilities, except facilities of the Department of Veterans Affairs, must be accredited by an approved accreditation body and certified by the Secretary of Health and Human Services.

The authority to approve accreditation bodies and to certify facilities was delegated by the Secretary to the FDA. On October 28, 1997, the FDA published the MQSA final regulations in the Federal Register. The final regulations became effective April 28, 1999, and replaced the interim regulations (58 FR 67558 and 58 FR 67565).

For the full guidance document, click here:

http://www.fda.gov/cdrh/mammography/cdrhDoc4B.html