|
| FDA Home Page | CDRH Home Page | Search | A-Z Index |  |
|
 |
||
  |
| Information for mammography facility personnel, inspectors, and consumers about the implementation of the Mammography Quality Standards Act of 1992 (MQSA) |
 |
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 February 11, 2009, FDA announced the approval for the Siemens Novation S, the Hologic Selenia S, and the Hologic Selenia Dimensions 2D Full Field Digital Mammography (FFDM) units.
The Novation S and the Selenia S are lower cost screening versions of the previously approved Novation DR and Selenia systems. The Novation S has its own quality control (QC) manual that is essentially the same as the QC manual for the Novation DR. Because of this similarity, facilities may use either one for QC testing. Currently, the Selenia S does not have its own QC manual, so facilities will be using the QC manual for the Selenia.
The Hologic Selenia Dimensions 2D is a newer version of the Selenia and has its own QC manual. This manual is similar to the Selenia QC manual with one important difference. Because Hologic has not yet applied for an alternative standard to the correction period when components of the Dimensions 2D fail QC tests, the failing components must be fixed prior to further clinical use. FDA expects Hologic to apply for an alternative standard similar to the one already granted to the Selenia unit
Because of the similarities between the new units and their respective precursors, FDA approves all accreditation bodies automatically to accredit these new units.
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 (ABs). Thus, FDA no longer accepts applications to extend existing MQSA certification to include these units.
The current FDA ABs 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 |
|||
Full Field Digital Mammography (FFDM) Unit |
ACR |
SAR |
SIA |
STX |
|---|---|---|---|---|
GE Senographe 2000D |
12/18/02 |
08/15/06 |
08/28/03 |
05/21/04 |
Fischer Imaging SenoScan |
07/24/03 |
|
|
05/21/04 |
Lorad/Hologic Selenia |
09/02/03 |
08/15/06 |
08/28/03 |
05/21/04 |
GE Senographe DS |
08/12/04 |
08/15/06 |
01/12/06 |
08/12/04 |
Siemens Mammomat Novation DR |
10/07/05 |
08/26/08 |
01/26/06 |
06/29/06 |
GE Senographe Essential |
06/29/06 |
08/15/06 |
08/24/06 |
09/05/06 |
Fuji Computed Radiography for Mammography |
11/13/06 |
10/12/06 |
11/13/06 |
11/13/06 |
Siemens Mammomat Novation S |
02/11/09 |
02/11/09 |
02/11/09 |
02/11/09 |
Hologic Selenia S |
02/11/09 |
02/11/09 |
02/11/09 |
02/11/09 |
Hologic Selenia Dimensions 2D |
02/11/09 |
02/11/09 |
02/11/09 |
02/11/09 |
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 Program
Division of Mammography Quality and Radiation Programs
FDA/CDRH/OCER
1350 Piccard Drive, HFZ-240
Rockville, MD 20850
Phone: 240-276-3332
Fax: 240-276-3272
Updated February 17, 2009
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH