By Bradley Merrill Thompson, Member of the Firm at Epstein Becker & Green
My wife complains I live in the future, and I suppose that’s true. But on the heels of three days of hearings last week by two subcommittees of the House Energy and Commerce Committee, all focused on mHealth, I feel the urge to plan for the regulatory world after FDA publishes its final guidance. FDA testified the...
How many mobile medical apps have received 510(k) clearance from the FDA? It's a question I get asked often. For a while the standard response that I've given and heard others give was that you could count on two hands how many apps have received FDA clearance. Over the course of the past two years, however, it has become clear that an increasing number of wireless-enabled medical devices with...
