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 multiple publications on the new mobile app regulation plan laid out by FDA Commissioner Gottlieb.
Following is an excerpt from MobiHealthNews, “New FDA Commissioner Lays Out Bold New Plan for Mobile App Regulation,” by Jonah Comstock:
FDA expert and Epstein Becker Green partner Bradley Merrill Thompson told MobiHealthNews in an email that this new direction is welcome news for him and many others in the industry who have long been frustrated by a lack of clarity from the agency.
“Since 2011, the CDS Coalition has been asking – indeed begging at times – for FDA to publish guidance that clarifies the scope of the agency’s regulation of clinical decision support software,” he wrote. “During the winter, after 21st Century Cures was signed into law, but before Dr. Gottlieb took over, FDA seemed still unsure what to do. Now FDA seems to be committing to publishing guidance in the coming months to clarify, beyond the legislation, what FDA will regulate in the area of clinical decision support and other such software. That is music to my ears.”
Thompson noted that Clinical Decision Support Coalition, an organization he is involved in the leadership of, has gone as far as to submit a citizen’s petition requesting this clarity. That petition includes a wish list of topics for FDA to address, including software associated with pharmaceuticals and, eventually, artificial intelligence. He’s also supportive of the new clearance pathway.
“In the blog post, Commissioner Gottlieb also seems to reference the discussions that industry has been having lately with FDA regarding adoption of the TSA pre-check idea as a better way of bringing new software to market,” Thompson wrote. “The blog post suggests that the agency is committed to this approach, which obviously we are delighted to hear. There is much good that can be done, although there is much work left to be done. It will be very important to get the details right.”
Related reading:
CNBC, “Medical Device Makers are Delighted at New FDA Plan: ‘Holy Smokes’ Says One Lawyer,” by Christina Farr.
Inside Health Policy, “FDA Launches Plan for Post-Market Regulation of Digital Medical Devices,” by Beth Wang. (Read the full version – subscription required.)
Medtech Insight, “US FDA’s New Game Plan for Digital Health,” by Ferdous Al-Faruque. (Read the full version – subscription required.)
FierceHealthcare, “The FDA is Finalizing a New Regulatory Plan for Digital Health and the Industry is Thrilled,” by Evan Sweeney.
Health Data Management, “IT groups backing FDA’s Digital Health Innovation Plan,” by Greg Slabodkin.
POLITICO Morning eHealth, “A Whole New FDA World,” by Darius Tahir.
