In a recent letter to the editor, an ITN reader brought up the decision made on May 23rd, 2006, to re-classify digital mammography from a Class III product to Class II. According to the reader, “This was widely thought to mean that the complicated and lengthy process of filing a PMA to gain FDA approval to market digital mammography would no longer be required.”
It was thought that the benefits of the proposed re-classification would enable a much simpler 510(k) application to FDA to be used to gain clearance to market digital mammography. In the meeting, Robert Jennings, M.D., of the FDA said: “The big difference which we feel goes a long way towards our goal of least burdensome approach to device clearance is that we will use, instead of a large clinical trial, simply reader evaluation of clinical films as is done in the ACR accreditation process.”
This would allow manufacturers entering the market to avoid the lengthy clinical study required in the PMA process. The new approach would also benefit patient care by not double exposing participants.
Although it was unanimously recommended that the FDA should develop the guidance documents required to reclassify digital mammography to a 510(k), nine months later, the FDA stated that it would take at least an additional one and a half to two years for the FDA to complete the guidance documents describing the requirements for a digital mammography 510(k). They added that the ultimate requirements would include a large clinical trial similar to that required for a PMA, including double exposure of participating patients and a one-year follow-up of negative diagnoses.
Why did the reader bring this to my attention? In hopes that other industry experts would join in on requesting that the FDA complete “the guidance documents for digital mammography 510(k) within the next six months” and “eliminate the need for a large clinical trial for a digital mammography 510(k).” This way, our reader believes, other qualified manufacturers would not be left sitting on the sidelines, while just a few players “divide up the large and growing digital mammography market.”
It begs the question – has the FDA established a fair playing field for all qualified manufacturers or does the market cater to a few powerhouses to lead the medical imaging market? That’s for you to decide. I just hope, above all, it’s catering to the patients.
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April 02, 2024 
