About the Mammography Program

Welcome to FDA's Mammography Program within the Center for Devices and Radiological Health. This website is designed to inform mammography facility personnel, inspectors, and other interested individuals about the implementation of the Mammography Quality Standards Act of 1992 (MQSA).

On June 1, 2004, the Office of Health and Industry Programs (OHIP) which houses the Division of Mammography Quality and Radiation Programs (DMQRP) was officially renamed the Office of Communication, Education, and Radiation Programs (OCER).

About Mammography Quality Standards Act (MQSA)

MQSA was signed into law on October 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. In the fall of 2004, Congress reauthorized MQSA, extending the program to 2007. The Act refers to the MQSA as amended by the Mammography Quality Standards Reauthorization Acts of 1998 and 2004 (MQSRA).

Congress charged FDA with developing and implementing MQSA regulations. Interim regulations, issued in December 1993, became effective in February 1994. In 1995, FDA began enforcing MQSA when it initiated an inspection program. On October 28, 1997, FDA issued more comprehensive final regulations, which became effective on April 28, 1999. Three amendments to the regulations have been published since they were first issued. These amendments have been incorporated in the amended final regulations.

Information on Approved Alternative Requirements is also available.

 Medicare Bill Passed - Public Law 110-275, July 15, 2008

Recently, Congress passed the Medicare Improvements for Patients and Providers Act (MIPPA) of 2008. Beginning January 1, 2012, MIPPA requires that "advanced diagnostic imaging services" (diagnostic magnetic resonance imaging, computed tomography, and nuclear medicine (including positron emission tomography)) be reimbursed only if performed by accredited facilities. To date, the Secretary has not approved any body to accredit facilities to perform advanced diagnostic imaging services .

Please note that this Act does not require accreditation of x-ray, mammography, ultrasound, or fluoroscopy services. Mammography facilities are already required to be accredited under the Mammography Quality Standards Act (MQSA). Therefore, MIPPA should have no impact on the accreditation of mammography facilities and the existing FDA-approved MQSA Accreditation Bodies.