March 26, 2015 — The U.S. Food and Drug Administration (FDA) released updated requirements for a mammography facility to extend its Mammography Quality Standards Act (MQSA) certification for digital breast tomosynthesis (DBT) systems.
All of the following information must be included with the application:
1: Manufacturers name of FFDM-DBT unit
2. Facility Status Information
a. Facility Name and FDA Facility ID Number
b. FDA Certificate Expiration Date
c. Current Accreditation Body for the 2D unit
d. Accreditation Expiration Date
e. Facility Contact Person for DBT unit
f. Contact Person’s Title
g. Contact Person’s Telephone, Fax, E-mail
h. Facility Address
i. Facility Owner
3. DBT Unit Identification
a. Machine Manufacturer
b. Machine Model
c. Year of Manufacture
d. Serial Number
e. Accreditation Body Unit Number
4. DBT Digital Image Receptor Identification (if interchangeable)
a. Receptor Manufacturer
b. Receptor Model
c. Year of Manufacture
d. Serial Number (if applicable)
5. Identification of Printer for Hard Copy Interpretation (mandatory even for facilities performing only soft copy interpretation)
a. Printer Manufacturer
b. Printer Model
c. Year of Manufacture
d. Serial Number
6. Final Interpretation Review Monitor Identification (if soft copy display is available)
a. Monitor Manufacturer
b. Monitor Model
c. Year of Manufacture
d. Serial Number
7. Phantom Identification
a. Phantom Manufacturer
b. Phantom Model
8. Hardcopy phantom image (3D mode) must be included when submitting application.
9. Personnel Qualifications
a. Interpreting Physicians who are qualified to interpret DBT mammograms (see Qualified Personnel)
b. Radiological Technologists who are qualified to perform DBT mammography examinations and the manufacturer recommended quality assurance tests (see Qualified Personnel)
c. Medical Physicists who are qualified to perform equipment evaluations and/or surveys of DBT mammography units (Qualified Personnel)
10. Complete Detailed report of Mammography Equipment Evaluation (MEE) (must have been conducted in accordance with 900.12(e)(10) within the 6 months prior to the request for use approval) must be included when submitting application.
a. Statement that equipment performance, as required under the following sections of the
MQSA final regulation 21 CFR 900.12(b), is met:
(1) Prohibited Equipment
(2) Specifically Designed for Mammography
(3) Motion of Tube-Image Receptor Assembly
(4)(iii) Removable Grid (if applicable to the DBT system used) (5) Beam Limitation and Light Fields
(6) Magnification
(7) Focal Spot Selection
(8) Compression
(9) Technique Factor Selection and Display
(10) Automatic Exposure Control
b. The results of quality control tests as required under the following sections of the
MQSA final regulations 21CFR 900.12(e):
(4)(iii) Compression Device Performance
(5)(i) Automatic Exposure Control Performance (if applicable to the DBT system used) (5)(ii) Kilovoltage Peak Accuracy and Reproducibility
(5)(iii) Focal Spot Condition (Resolution) (5)(iv) Beam Quality and Half-Value Layer
(5)(v) Breast Entrance Air Kerma and AEC Reproducibility (if applicable to the DBT
system used) (5)(vi) Dosimetry
(5)(vii) X-Ray Field/Light field/Image receptor/Compression paddle alignment
(5)(ix) System Artifacts
(5)(x) Radiation Output
(5)(xi) Decompression (or alternative standards allowed for these requirements) (6) Quality Control Tests – Other Modalities (Facilities must perform all DBT manufacturer recommended quality control tests including the medical physicist’s tests for Soft Copy Display system)
c. The results of the phantom image quality tests, including a sample image
d. If any of the requirements in 8 a, b, or c are not met, submit documentation of successful corrective action
e. If any of the requirements in 8 a or b are not performed, explain why the requirement is not applicable
f. Date of the MEE
g. Name and address of the physicist(s) who performed the MEE
11. DBT Manufacturer’s Quality Control Program
a. Name of the Quality Control Manual
b. Year published
c. Revision number, if not the original
d. Printing number, if not the original
12. Signature of facility contact person for the DBT unit
Note 1: Under MQSA, each manufacturer’s Digital Breast Tomosynthesis system is currently considered a separate new mammographic modality, and the personnel requirements for new modality training apply.
Note 2: In order to use the tomosynthesis portion of the unit, the facility must apply to FDA to have its certificate extended to include that portion of the unit. The certification extension only applies to the DBT portion of the unit. The facility must have the 2-D portion of the unit accredited by one of the accreditation bodies already approved to accredit the 2-D portion.
For more information: www.fda.gov
July 29, 2024 
