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 Medtech Insight, in “‘Cures’ Bill Circumvents FDA On Medical Software Regs,” by Ferdous Al-Faruque. (Read the full version – subscription required.)
Following is an excerpt:
Thompson says FDA’s ambiguity over what kinds of medical software it intends to regulate has so far complicated matters for the industry.
“FDA says that they regulate high-risk clinical decision support software, but not low risk software,” said Thompson. “That’s great, but how is a company supposed to discern high from low risk in FDA’s eyes if the agency won’t publish a guidance? Companies have to know the answer to that question because it is fundamental to both the cost and timelines associated with product development. Investors run away from software that has an uncertain path forward.”
Thompson, who was skeptical of some prior-year versions of the SOFTWARE Act, praised the language in the Cures bill, stating it would provide a high level of clarity. As an example, he says, under the bill, clinical decision support software that simply allow physicians to double check their clinical recommendations are not going to be regulated by FDA, a point that will ease the burden on CDS software companies.
“We are delighted to see that Republicans and Democrats have come together over these concepts to provide industry with the needed clarity,” Thompson said. “We hope Congress moves forward, and look forward to working with FDA to implement these principles.”