The US Food and Drug Administration has developed a comprehensive website to inform mammography facility personnel, inspectors, and other interested individuals about the implementation of the Mammography Quality Standards Act (MQSA) of 1992. The US Congress enacted MQSA to ensure that all women have access to quality mammography for the detection of breast cancer in its earliest, most treatable stages. The FDA/MQSA website is available at http://www.fda.gov/cdrh/mammography

• Mammography Matters Newsletter
• MQSA Regulations Guidance
• Patient Information on MQSA 

Users may subscribe to receive email alerts and highlights of the FDA/MQSA website as they become available by visiting http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMQSA/mail/listman.cfm

Mammography Matters Newsletter

Mammography Matters is an electronic, quarterly newsletter produced by the FDA's Division of Mammography Quality and Radiation Programs. Through the Winter 2000 issue, the FDA published and distributed hard copies of Mammography Matters at no cost. Starting with the Spring 2000 issue, the FDA only publishes the electronic version of Mammography Matters that is posted on the FDA website.

Users may subscribe to receive email alerts and highlights of the FDA/MQSA website as they become available by visiting http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMQSA/mail/listman.cfm

The current issues of Mammography Matters are available online in HTML format:

Spring 2000, Volume 7, Issue 3
http://www.fda.gov/cdrh/mammography/mmweb/mmweb73
Spring 2000, Volume 7, Issue 2
http://www.fda.gov/cdrh/mammography/mmweb72/index.html
Winter 2000, Volume 7, Issue 1
http://www.fda.gov/cdrh/mammography/mmweb/mm-web.html

The following issues of Mammography Matters are available for download in PDF format:

Summer 2000, Volume 7, Issue 3
http://www.fda.gov/cdrh/mammography/pubs/mmsum2k.pdf
Spring 2000, Volume 7, Issue 2
http://www.fda.gov/cdrh/mammography/pubs/MM4-00.pdf
Winter 2000, Volume 7, Issue 1
http://www.fda.gov/cdrh/mammography/pubs/MM1-00.pdf
Fall 1999, Volume 6, Issue 4
http://www.fda.gov/cdrh/mammography/pubs/MMfall99.pdf
Summer 1999, Volume 6, Issue 3 http://www.fda.gov/cdrh/mammography/pubs/MMsumm99.pdf
Spring 1999, Volume 6, Issue 2 http://www.fda.gov/cdrh/mammography/pubs/mmspring.pdf
Winter 1999, Volume 6, Issue 1 http://www.fda.gov/cdrh/mammography/pubs/mmwin99.pdf
Fall 1998, Volume 5, Issue 4
http://www.fda.gov/cdrh/mammography/pubs/mmfall98.pdf
Summer 1998, Volume 5, Issue 3 http://www.fda.gov/cdrh/mammography/pubs/mmsum98.pdf
Spring 1998, Volume 5, Issue 2 http://www.fda.gov/cdrh/mammography/pubs/mmspring98.pdf
Winter 1998, Volume 5, Issue 1 http://www.fda.gov/cdrh/mammography/pubs/mmwin98.pdf

MQSA Regulations Guidance

The FDA/MQSA website provides an extremely useful "guidance" section which interprets MQSA regulations and addresses compliance issues. This tool is meant to help facilities comply with MQSA regulations, but it does not have the force of law. If facilities follow the guidance developed for a specific MQSA requirement, they will be considered to have met the requirement. However, as guidance is intended to guide, not mandate, facilities may identify other ways of meeting MQSA requirements.

In contrast, the MQSA final regulations are national quality standards for mammography services. Written by the FDA, these regulations are based on MQSA of 1992 and MQSA Reauthorization of 1998. They have the force of law. Words such as "shall," "must," and "require" are used when stating statutory or regulatory requirements.

The FDA MQSA Guidance follows the Good Guidance Practices protocol. The FDA receives questions from the mammography community, develops and publishes proposed guidance, receives and evaluates comments from the public, and finalizes the guidance.

Documents that provide approved guidance in complying with MQSA requirements are available in PDF format at http://www.fda.gov/cdrh/mammography/guidance-docs.html

The FDA has developed the Policy Guidance Help System (PGHS) which is available online at http://www.fda.gov/cdrh/mammography/robohelp/finalregs.htm or as a software application that may be downloaded from the above page and run on your own computer. To view or use the PGHS website version, your browser must be Java enabled.

Users may subscribe to receive email alerts and highlights of the FDA/MQSA website as they become available by visiting http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMQSA/mail/listman.cfm

Updated: September 25, 2007