The End of the FDA MQSA Certification Extension Program for Tomosynthesis Systems

On April 6^th, FDA announced that it would no longer accept applications for the Digital Breast Tomosynthesis (DBT) Certificate Extension program. On April 9^th, 4 mammography accreditation bodies (the American College of Radiology and the states of Arkansas, Iowa, and Texas) began accepting applications for DBT accreditation. This change, while coming as a surprise to many physicists and facilities, has been in progress for some time.

The Mammography Quality Standards Act (MQSA) requires all breast imaging systems to be accredited by an approved organization. In the case of a new technology, the FDA will provide provisional accreditation through the certificate extension program until the accrediting organizations can develop their own programs. This process has been used in the past, including when full-field digital mammography was introduced. While many facilities may have been caught off-guard, it was never the intention of the FDA to manage the certificate extension program in perpetuity.

As the ACR handles the largest number of mammography systems in the country, this article will focus on their accreditation program. State programs are similar, but if you are working in one of those states, it is your responsibility to ensure you meet those state requirements for DBT accreditation. The ACR DBT accreditation program exists under the Mammography Accreditation Program and is very similar with respect to program requirements, submission process, and cost. All DBT systems are required to achieve both FFDM and DBT accreditation. For facilities that may not use the 2D capabilities of their unit, they will still have to accredit the 2D system in order to be in compliance. Overall, the ACR accreditation program will cost facilities an additional $1,500 for each DBT unit at their facility (confirm your fees with the ACR).

For facilities that are within their 2D re-accreditation process, they should have been contacted already by the ACR to include DBT accreditation with their current application. For facilities that will be renewing in the future, they will be required to include the DBT accreditation program with their next renewal. This will allow the ACR to do initial DBT accreditation over the next few years for units that were recently approved and have a valid FDA Certificate Extension program approval.

The ACR provided updated Medical Physicist Summary forms for those manufacturers with FDA approved DBT systems (Hologic, GE, Siemens, and Fuji). The forms use the standard ACR format, but include the additional DBT required tests. In some cases, the test numbers have changed and for GE, there are now separate forms for FFDM and Pristina systems as the tests required for these systems are significantly different. Technologist QC summary pages are also updated to reflect the DBT systems. The updated forms provided by the ACR help to standardize physicist reporting of DBT test results and should be implemented for all DBT systems that will be submitted for accreditation.

Additionally, the ACR has been requiring the FDA Certificate Extension Approval letter that the facility originally received from the FDA and MQSA Mammography Equipment Checklist for all DBT systems going through the DBT accreditation program. For many physicists, the Equipment Checklist is only provided at acceptance testing, but it will now be required during the first ACR application for DBT.

For phantom images, the ACR requires a DBT best slice image of the ACR accreditation phantom. This is the same image that has been submitted to the FDA for the certificate extension program, so it should be familiar to most of us. Most phantom images are now submitted electronically and the acceptable formats for the best slice DBT image are DICOM, JPEG, JPG, PNG, GIF, TIFF, and BMP. FFDM images submitted electronically must be in uncompressed DICOM format. For the 2D FFDM program, a synthesized phantom image will not be accepted: A standard, 2D image must be submitted.

For clinical images, the ACR will not accept 3D image sets. However, there are a number of options for facilities based on how they use the DBT systems clinically. For systems that have 2D synthesized images available, facilities may submit a 2D clinical set, a 2D synthesized clinical set, a 2D cc and a 2D synthesized MLO, or a 2D synthesized CC and a 2D MLO for their FFDM accreditation and a 2D synthesized set, a 2D CC and a 2D synthesized MLO, or a 2D synthesized CC and a 2D MLO for the DBT accreditation program. If a unit does not have the capability to do synthesized 2D images, then that facility will need to submit a complete 2D set of images for both the FFDM and DBT accreditation programs. The ACR recommends that facilities submit images from different patients for the 2D and 3D clinical images, but will accept the same patient if necessary.

For more information on the ACR accreditation program for DBT, please refer to the ACR website.