If your site is already MQSA certified in FFDM
Tomosynthesis units will be accredited under facility's existing FFDM certification through FDA's FFDM Certification Extension Program. To become breast tomosynthesis certified your site must apply to the MQSA for a 3D extension certification.
Once an application is sent for breast tomosynthesis approval, it will take approximately 14 days for the MQSA to process and approve/deny the request. At this time only the MQSA will need to approve breast tomosynthesis imaging at your site. Neither the state nor ACR is involved in the approval process to date. If you have any questions please contact Denise Robinson at the FDA with
MQSA Certification Extension Program
If your site is not yet MQSA certified in digital mammography
If your site has not yet been FFDM accredited, you will need to apply to the ACR or State for FFDM certification. Once that is received, you may contact the Denise Robinson at the FDA for the FFDM certification.