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

Digital Accreditation

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.

FDA Approved Full Field Digital Mammography Systems (FFDM)

FDA approved the following FFDM units for use in mammography facilities as indicated by date:

• Siemens Mammomat Novation DR Full Field Digital Mammography (FFDM) System on 08/20/04
   
• GE Senographe DS Full Field Digital Mammography (FFDM) System on 02/19/04
  
• Lorad/Hologic Selenia Full Field Digital Mammography (FFDM) System on 10/2/02
   
• Lorad Digital Breast Imager Full Field Digital Mammography (FFDM) System on 03/15/02
   
• Fischer Imaging SenoScan Full Field Digital Mammography (FFDM) System on 09/25/01
   
• GE Senographe 2000D Full Field Digital Mammography System on 01/28/00

As of the dates listed below under the heading “FDA Approved Accreditation Bodies for FFDM Units”, facilities with these FFDM units must apply for accreditation from one of the FDA-approved accreditation bodies. Thus, FDA no longer accepts applications to extend existing MQSA certification to include these units.

FDA Approved Accreditation Bodies for FFDM Units

The current FDA Accreditation Bodies (AB) approved to accredit FFDM units are:

American College of Radiology (ACR)

GE Senographe DS Full Field Digital Mammography (FFDM) units (approved 08/12/04; effective 09/15/04).

Lorad/Hologic Selenia Full Field Digital Mammography (FFDM) units (approved 09/02/03; effective 09/15/03).

Fischer Imaging SenoScan Full Field Digital Mammography (FFDM) units (approved 07/24/03; effective 08/15/03).

GE Senographe 2000D Full Field Digital Mammography (FFDM) units (approved 12/18/02; effective 02/15/03).

The State of Iowa (SIA)

GE Senographe 2000D and Lorad/Hologic Selenia Full Field Digital Mammography (FFDM) units within Iowa (approved 08/28/03; effective 10/01/03).

The State of Texas (STX)

GE Senographe DS Full Field Digital Mammography (FFDM) units within Texas (approved 08/12/04; effective 09/15/04).

Fischer Imaging SenoScan, GE Senographe 2000D and Lorad/Hologic Selenia Full Field Digital Mammography (FFDM) units within Texas (approved/effective 05/21/04)

MQSA Certification Extension for GE Senographe DS FFDM Units

As of September 15, 2004, the FDA will no longer accept applications for the GE Senographe DS Full Field Digital Mammography (FFDM) units.

MQSA Certification Extension for Siemens Mammomat Novation DR FFDM Units

There is currently no FDA-approved AB to accredit the Siemens Mammomat Novation DR Full Field Digital Mammography (FFDM) unit. Until the FDA approves an AB to accredit this unit, FDA will continue the process for extending the certification of an already certified facility to include this model FFDM unit. Until otherwise notified by FDA, a facility with the Siemens Mammomat Novation DR model will be exempt from the MQSA accreditation requirement. However, facilities with this unit must submit a written request to FDA to extend its current certification to cover this FFDM model before using it on patients.

If you have any questions, please contact the MQSA facility hotline at 1-800-838-7715.

Updated August 27, 2004

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