Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MedTech Insight, in “Industry Optimistic About Second CDS Draft Guidance; FDA Releases More Final Software Guidances,” by Ferdous Al-Faruque. (Read the full version – subscription required.)
Following is an excerpt:
Bradley Merrill Thompson, an attorney with Epstein Becker & Green, has been perhaps the most vocal critic of the original draft guidance. As the spokesperson for the now-defunct CDS Coalition, he has fought for the FDA to adopt the IMDRF’s risk-based approach. While he says the new draft guidance does that better, it still doesn’t go far enough in his view.
“This is progress, albeit maybe smaller steps than it might otherwise appear,” Thomson told MedTech Insight. “FDA is re-proposing its CDS guidance to address many of the concerns that the CDS Coalition expressed nearly two years ago.”
The main concern Thompson raised was to ask the FDA to take a risk-based approach, and now it appears the agency has not only adopted that approach, but also the one specifically asked for by the coalition. Despite the progress, he says the agency only took a “very small step.”