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 Inside Heath Policy, in “FDA Seeks to Prevent Opioid Overdoses Through Its First-Ever Mobile App Challenge.” (Read the full version – subscription required.) His comments also appeared in FDA Week, Inside Health Reform, and Health Policy Newsstand.
Following is an excerpt:
Bradley Thompson, a member of the firm Epstein, Becker & Green and general council for the mHealth Regulatory Coalition that works on regulatory issues of mobile medical apps, told Inside Health Policy that it is unlikely such an app would require premarket review, but highlighted FDA's enthusiasm around mobile health apps.
“FDA is definitely enthusiastic about the possibilities with mobile apps,” wrote Thompson. “Indeed, in the 30 years I've been practicing in this space, I've never seen FDA take to a technology with more enthusiasm than mobile apps. I think the agency sees tremendous opportunity, as does nearly everyone else. That said, they still need to be the regulator in the room. They need to ask the tough questions. But frankly they are cheering for app developers.”