The FDA have made an announcement that would reclassify FFDM systems from the current class III category, which requires premarket approval (PMA) applications, to class II, which requires the less rigorous 510(k) process. The reclassification would eliminate or reduce the requirement for vendors to conduct large-scale multireader, multicase (MRMC) clinical trials prior to submitting applications for equipment approval.
If the proposal is adopted, the FDA will rely upon well-designed bench studies and limited clinical testing in lieu of large-scale MRMC clinical studies. Products using new technology, with dissimilar designs from approved systems, or having indications for use that are dissimilar from legally marketed devices of the same type, may be required to collect additional clinical data.
An MRMC study may be required to compare sensitivity, specificity, and receiver operating characteristic curves if the results of physical laboratory testing and mammographic feature analysis raise concerns by the FDA.
Vendors have been quick to respond, even with comments that the CR mammography market, particularly in Europe will not be affected due to the initial fast and extensive uptake of CR, but that newer technologies will get to market sooner. This is reflected in the announcement by Hologic, that they plan to have a device for tomosynthesis released at RSNA in 2009.
However, tomosynthesis may need to be subject to a large trial like the DMIST study, as it's eventual aim is to become the main screening tool for breast cancer detection.
