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Information for mammography facility personnel, inspectors, and consumers              
about the implementation of the Mammography Quality Standards Act of 1992 (MQSA)
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Facility Certification and Inspection

General Information
Requirements
Preparing for an Inspection
Inspection Fees
Accreditation Bodies
Digital Accreditation
Revised MQSA Policy on Follow Up for Inspection Violations
Facility Warning Letters

General Information

Note to Mammography Facility Staff: To get a quick response to your questions about MQSA or other concerns, call our MQSA Facility Hotline at 1-800-838-7715, rather than submitting your questions by E-Mail.

The number of MQSA-certified mammography facilities operating in the United States can be found on the Scorecard Statistics page.

Facilities that fail accreditation must cease providing mammography services. However, once the deficiencies leading to failure have been corrected, a facility may apply for reinstatement to resume the accreditation process. FDA uses a state-of-the-art database, which tracks certification, inspections, and accreditation information, that allows it to assess facilities' compliance with MQSA.

For an overview of the MQSA requirements, click on "Requirements" from the options on your left.

For more detailed information about becoming accredited and certified, refer to the Accreditation and Certification section of the Policy Guidance Help System.

For more information on "MQSA Inspections," including Preparing for MQSA Inspections, and "Inspection Fees," click on the appropriate button to your left.

MQSRA Inspection Demonstration Program

The Mammography Quality Standards Reauthorization Act of 1998 (MQSRA) authorizes FDA to establish a demonstration program under which FDA would conduct inspections of selected facilities less frequently than the annual requirement specified in MQSA. [More Information]

States as Certifiers Demonstration Project

In June 1996, FDA established a States as Certifiers (SAC) Working Group to assist in developing procedures and regulations for the transfer of certification authority from FDA to the States, as provided for by MQSA.

In August 1998, FDA implemented a SAC Demonstration Project with the States of Iowa and Illinois. The demonstration was scheduled for one year with an option for renewal, which was exercised. Regulations to implement the program on a nationwide basis are projected to go into effect around April 2001.

Responsibilities delegated to the participating States include:

MQSA Certificates Change Size

In Fall 2001, MQSA certificates will change in size from the present 11"x14" to an 8-1/2"x11" size. Everything else about the certificate will remain the same. This new, more "user friendly" size will replace a facility's old certificate at the facility's time of renewal.

Beginning Spring 2003, FDA/MQSA facility certificates will include only the name of the facility certified, but not the facility's address. Facilities should continue the practice of reporting their address changes to their accreditation body.

Updated April 2, 2004

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