Bradley Merrill Thompson, a 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 “Cures Exempts Some Medical Software; More Clarity Needed, Attorneys Say,” by David Lim. (Read the full version – subscription required.)
Following is an excerpt:
Thompson agreed, saying the uncertainty with the Trump administration might delay a CDS guidance even further, despite a need for additional clarity over what is considered low-risk or high-risk software.
"What FDA considers high versus low risk is still unclear -- so we're still very desperately waiting for FDA to publish the guidance document and I have no idea even now if that is going to happen," Thompson said to IHP. He added that he would have liked to see a directive in Cures for FDA to issue the CDS guidance, but said that would have been controversial because the guidance might have been viewed as a new regulation.
"CDS guidance may be viewed as increasing regulation, I don't view it that way, but it's caught up in politics now. Honestly I'm very frustrated, there seems to be always some reason not to publish it. Industry is not a mind reader; we cannot read FDA's mind about what it considers software that needs to be regulated. FDA is sort of absent from all of this, if they are not going to regulate it, that's fine too, but it's the ambiguity that is so frustrating. There are a lot of ethical companies that want to get into software but don't know what the regulatory pathway looks like."
FDA should issue narrowly crafted advisory opinions to clarify regulatory decisions for new technologies in order to more timely get information to industry, Thompson previously said in an Aug. 16 citizen petition to FDA on behalf of the CDSC.