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 Bloomberg BNA Health IT Law & Industry Report, in “Software Companies Push FDA for Guidance on Decision Support Tools,” by Alex Ruoff. A version of this article also appeared on Bloomberg BNA Health Care Blog.
Following is an excerpt:
Members of two industry groups that represent makers of clinical decision support (CDS) technologies met with Food and Drug Administration officials earlier in February to discuss how the agency plans to regulate CDS tools, an FDA spokeswoman confirmed for Bloomberg BNA Feb. 18.
CDS technology developers are growing frustrated with the lack of guidance from the FDA, Bradley Merrill Thompson, a device and combination product attorney at Epstein Becker & Green PC in Washington, told Bloomberg BNA. FDA administrators also have been inconsistent on what they tell manufacturers about their plans to regulate CDS software.
“If you talk to three people at FDA you're likely to get three opinions about what is or isn't regulated,” Thompson, who serves as general counsel to the CDS Coalition and the Combined Product Coalition, said. Both groups met with FDA earlier this year, he said.
