Reports (MQSA)

• Mammography Facility Adverse Event and Action Reports
• Report to Congress on Performance of Accreditation Bodies
• Assessment of the Availability of Mammography Service
• GAO Reports

 Mammography Facility Adverse Event and Action Reports
(formerly Mammography Facility Adverse Event Report;
annual report mandated by MQSA, Sec. 354(l)):

• Mammography Facility Adverse Event and Action Report - October 25, 2012
• Mammography Facility Adverse Event and Action Report - August 3, 2012
• Mammography Facility Adverse Event and Action Report - May 2, 2012
• Mammography Facility Adverse Event and Action Report - November 25, 2011
• Mammography Facility Adverse Event and Action Report - July 18, 2011
• Mammography Facility Adverse Event and Action Report - June 15, 2011
• Mammography Facility Adverse Event and Action Report - March 21, 2011

Previous reports have been archived.

 Report to Congress on the Performance of Accreditation Bodies

2010 Report

This is the fifteenth annual Report to Congress on the performance of accreditation bodies under the Mammography Quality Standards Act (MQSA) of 1992, as amended by the Mammography Quality Standards Reauthorization Act of 2004. The Report, prepared according to Section 2 of the law, covers the period from January 1, 2010 to December 31, 2010 on the performance of the following accreditation bodies: the American College of Radiology (ACR); the State of Arkansas (SAR); the State of Iowa (SIA); and the State of Texas (STX).

• Full Report [PDF]

Previous reports have been archived.

 Assessment of the Availability of Mammography Services

FDA's analysis of the availability of mammography services and the changes in demand for, and supply of, mammograms in recent years. (December 18, 2001)

 GAO Reports 

GAO Reports (mandated by MQSA, Sec. 3 of Pub.L. 102-539)

• Mammography Services: Initial Impact of New Federal Law Has Been Positive (October 1995) [PDF]
• Mammography Services: Impact of Federal Legislation on Quality, Access, and Health Outcomes (October 1997) [PDF]

GAO Reports (other)

• Mammography - Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations (July 2006) [PDF]
• Mammography: Capacity Generally Exists to Deliver Services (April 2002) [PDF]
• Regulatory Management: Communication About Technology-Based Innovations Can Be Improved (February 2001) [PDF]

This report cites OCER/DMQRP's MPRIS as a "noteworthy" example of an innovative effort at collecting information through electronic reporting, along with four other FDA information technology (IT) systems. The report notes FDA's Center for Devices and Radiological Health has developed an Internet-based Mammography Program Reporting and Information System to support the agency's statutorily mandated responsibility for certification and inspection of all mammography facilities in the United States.

• Mammography Quality Standards Act - X-ray Quality Improved Access Unaffected, but Impact on Health Outcomes Unknown (May 1998) [PDF]