Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, wrote an article titled "After FDA's Mobile Medical Apps Final Guidance, What's Next?"
Following is an excerpt:
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 guidance should be out by October 1 of this year, but I would guess actually it will probably be out by mid-summer. I'm just basing that on the belief that FDA is now highly motivated to get the darn thing out.
So what happens then? What are the regulatory issues we in the mobile health arena will need to address after FDA's guidance finally sees the light of day?
