Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FDA Week, in “2nd Cures Draft Pegs Low-Risk Software Exempt from FDA, but Gives Agency Some Latitude,” by Erin Durkin.
Following is an excerpt:
Bradley Thompson, an attorney at Epstein Becker & Green, said that while the second draft appears to include various perspectives from different stakeholders, he is concerned that some of the new language is difficult to interpret and may accidentally introduce more uncertainty into the process.
Thompson noted the January draft stated that clinical decision software would not be regulated so long as the software offered “the opportunity for additional interpretation or an independent confirmation” of the recommendations the software makes. He said that seemed pretty clear and easy to interpret.
But the second draft gives FDA discretion to determine whether a particular category of clinical decision software would pose significant risk to patient safety based on a “whole litany” of factors. “It would seem that the new process gives FDA quite a bit of latitude to decide what to regulate,” he said. “But the original purpose of this legislation was to more clearly define the dividing line between regulated and unregulated software.”
Thompson said that he would like to see sponsors adopt language that more clearly differentiates regulated from unregulated clinical decision software, “rather than simply kicking the ball back to FDA.”
