What mHealth will the FDA regulate? (US)

Donna Cusano

Neon sign ‘pointer to the future’: The mHealth Regulatory Coalition [TA 17 July, 24 June] just published a 61 page white paper, ‘A Call for Clarity’, that examines what mHealth products are likely to be regulated by the FDA and what classification(s) might apply. A strong caveat in the report is that ‘The Coalition’s mission is to drive the analysis to a level of specificity that would be meaningful to the FDA’, not to propose solutions, and ensure an understanding of the problem. Rather their goal is to work with the FDA to draft a guidance document by March 2011. Lead author Bradley Merrill Thompson and his firm Epstein, Becker & Green PC are familiar names to our readers; credit also to Epstein, Becker co-authors Leah Kendall, M. Jason Brooke plus Dane Stout of Anson Group LLC. Coalition website. White paper (PDF)