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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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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.
On August 26, 2008 and effective immediately, the Food and Drug Administration (FDA) approved the SAR to accredit the Siemens Mammomat Novation DR Full Field Digital Mammography (FFDM) unit. Arkansas applicants with this type of unit may contact the SAR and apply for the accreditation of that unit.
Applicants with FFDM units other than the GE Senographe Essential, GE Senographe 2000D, GE Senographe DS, Fischer SenoScan, Lorad/Hologic Selenia, and Siemens Mammomat Novation DR, and the Fuji Computed Radiography Mammography Suite must continue to apply to and be approved by the FDA for extension of their certificates to include the use of an FFDM unit in order to operate those units legally.
If you have questions, please contact the SAR at (501) 661-2301.
FDA approved the following FFDM units for use in mammography facilities as indicated by date:
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.
The current FDA Accreditation Bodies approved to accredit FFDM units are the American College of Radiology (ACR), the State of Arkansas (SAR), the State of Iowa (SIA), and the State of Texas (STX).
| Accreditation Body Approval Date Effective Date |
||||
|---|---|---|---|---|
| Full Field Digital Mammography (FFDM) Unit | ACR | SAR | SIA | STX |
| GE Senographe 2000D | 12/18/02 02/15/03 |
08/15/06 08/15/06 |
08/28/03 10/01/03 |
05/21/04 05/21/04 |
| Fischer Imaging SenoScan | 07/24/03 08/15/03 |
05/21/04 05/21/04 |
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| Lorad/Hologic Selenia | 09/02/03 09/15/03 |
08/15/06 08/15/06 |
08/28/03 10/01/03 |
05/21/04 05/21/04 |
| GE Senographe DS | 08/12/04 09/15/04 |
08/15/06 08/15/06 |
01/12/06 01/17/06 |
08/12/04 09/15/04 |
| Siemens Mammomat Novation | 10/07/05 10/15/05 |
08/26/08 08/26/08 |
01/26/06 02/01/06 |
06/29/06 06/29/06 |
| GE Senographe Essential | 06/29/06 07/15/06 |
08/15/06 08/15/06 |
08/24/06 08/24/06 |
09/05/06 09/05/06 |
| Fuji Computed Radiography for Mammography | 11/13/06 11/15/06 |
10/12/06 10/12/06 |
11/13/06 11/13/06 |
11/13/06 11/13/06 |
Applicants with FFDM units other than the units listed in the table above must continue to apply to and be approved by the FDA for extension of their certificates to include the use of an FFDM unit, in order to operate those units legally. Requests for FFDM certification extension need to include all the information listed in the document MQSA Facility Certification Requirements for Use of Full Field Digital Mammography (FFDM) and should be forwarded to:
FFDM Certification Extension ProgramIf you have any questions, please contact the MQSA facility hotline at 1-800-838-7715 or by e-mail at MQSAhotline@hcmsllc.com.
Updated September 2, 2008
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