Thompson Featured in Article About FDA Regulation of Mobile Health ProductsBNA's Medical Devices Law & Industry Report August 25, 2010
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice in the Washington, DC, office, was featured in an article about FDA regulation of mobile health products.
The article discussed how members of the mHealth Regulatory Coalition have begun to draft proposed guidance to the Food and Drug Administration on how to regulate mobile health products. The Coalition is focused on three primary issues they believe, if addressed properly by FDA, would provide much-needed clarity for how mobile health products will be regulated.
Medical devices intended for medical use are regulated differently from those intended for so-called health and wellness use, explained Thompson, who is involved with the Coalition.
Thompson told BNA he expects the Coalition to begin in September working on a 90-day plan to fact-find, learn, and share findings about the mobile health space among Coalition members and with FDA, and begin developing solutions toward proposed guidance to FDA.