Welcome to the FDA's Mammography Program within the Center for Devices and Radiological Health. This website informs mammography facility personnel, inspectors, and other interested individuals about the implementation of the Mammography Quality Standards Act of 1992 (MQSA).
In October 2012, the Division of Mammography Quality Standards, formerly the Division of Mammography Quality and Radiation Programs, moved to the newly named Office of In Vitro Diagnostics and Radiological Health.
About Mammography Quality Standards Act (MQSA)
MQSA became law on Oct. 27, 1992. 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 Act refers to the MQSA as amended by the Mammography Quality Standards Reauthorization Acts of 1998 and 2004 (MQSRA).
Congress tasked the FDA with developing and implementing MQSA regulations. Interim regulations, issued in December 1993, became effective on Oct. 1, 1994. The FDA began enforcing the accreditation and certification provisions of the Act on that date, and began annual inspections of mammography facilities in January 1995. On Oct. 28, 1997, the FDA issued more comprehensive final regulations, which became effective on Apr. 28, 1999. Reauthorizations of MQSA came with new requirements, which were incorporated into the regulations.
Information on Approved Alternative Requirements is also available.