Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "FDA, Industry Groups Launch mHealth Educational Outreach Tour."
Following is an excerpt:
The MMA Roadshow kicks off months after FDA issued final guidance on mHealth applications and ahead of a congressionally-mandated report on a risk-based regulatory framework for health information technology.
FDA will collaborate with more than a dozen industry trade groups and six universities to develop a series of educational programs designed to help mobile app developers learn about FDA requirements for high risk products. Industry members of the consortium include the Food and Drug Law Institute, the mHealth Regulatory Coalition, the Wireless Life Sciences Alliance, the National Venture Capital Association, and the Regulatory Affairs Professional Society. ...
Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition and chairman of the steering committee for the program, noted that the MMA Roadshow is an efficient way for FDA to speak to a large number of mobile app developers about its guidance. There is probably a greater need for FDA education in mHealth than elsewhere, he added.
"Basically there are 12 national organizations promoting these meetings to their members, so rather than go to individual meetings with each individual association, (Patel is) able to cover all 12 of them at once," he said. "They will be very large meetings, probably all of them over 100, and all specific to the FDA guidance." ...
Thompson said industry roadshow speakers intend to give innovators support by sharing their experiences with FDA regulation. The goal of the program is to encourage the development of apps that are higher in risk but that also offer higher benefits, he said.
"Mobile apps offer incredible opportunities to improve the quality of care, as well as its effectiveness, and so far developers have barely scratched the surface," he said. "We hope to help more companies enter this space."
