Bradley Merrill Thompson Discusses FDA Announcement of Digital Health Innovation Action Plan and Launch of Pre-Cert Pilot Program

Multiple Publications

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 topic of the FDA’s digital health innovation action plan and launch of pre-certification pilot program.

Following is an excerpt from MobiHealthNews, “FDA Opens Applications for Digital Health Pre-Certification Pilot Program,” by Jonah Comstock:

Bradley Merrill Thompson, an attorney with Epstein Becker Green who advises digital health companies on FDA interactions, said he thinks the program is an impressive step forward.

“I think the idea of a pilot program is brilliant, and not just because we were one of the groups to propose it,” he wrote in an email. “This stuff is really hard to figure out in the abstract, and it’s really only by working with companies and tinkering and experimenting that we can truly identify the best model.”

Thompson also said he agrees with Gottlieb that the FDA isn’t likely to be hurting for applications, despite a lack of clear advantages for companies that choose to participate.

“What is not very clear, and companies will need to take it on faith, is exactly what benefit they will get out of participating in the pilot,” he wrote. “The FDA is not very committal about exactly what requirements will be applied to the digital health products these companies produce. So companies will need to approach this from the standpoint of, by participating with FDA, we will learn much about the program and be that much farther ahead when the permanent program is put in place. And I do think that is a significant carrot. I was, at the same time, impressed that FDA is suggesting that perhaps this certification program could make it unnecessary to file a 510(k) at all for certain presumably low risk digital health products. I think that’s fantastic.”

Related reading:

CNBC, “The FDA Did a Good Thing for Digital Health Today -- Even Skeptics Agree,” by Christina Farr.

HealthDataManagement, "FDA Lays Out Digital Health Plan to Foster Innovation," by Greg Slabodkin.

FierceHealthcare, “FDA Unveils Precertification Pilot Program for Digital Health Technology, Maps Out Upcoming Guidance,” by Evan Sweeney.

Bloomberg BNA Medical Devices Law & Industry Report, "FDA's Pilot Program on Software Regulation Garners Praise," by Mike Stankiewicz. (Read the full version - subscription required.)

PoliticoPro, "FDA Opens Up Digital Health Pre-Certification Pilot Program," by Darius Tahir. (Read the full version - subscription required.)

Medtech Insight, “Software at The Speed of Trust: US FDA Launches Pilot to Expedite Digital Health Products,” by Ferdous Al-Faruque. (Read the full version – subscription required.)

MedTech Insight, "Industry Praise US FDA Software Pilot Program," by Ferdous Al-Faruque. (Read the full version - subscription required.)

Inside Health Policy, “FDA Lays Out Plan to Loosen Regulation of Medical Device Software,” by Beth Wang. (Read the full version – subscription required.)

BioWorld MedTech, "FDA's Digital Health Action Plan Includes Pilot Program for Precertification," by Mark McCarty.