Update Nov Dec 2013 - (Page 20)

What FDA's Final Guidance on Mobile Medical Apps Means for Industry By Daniela Pirvu On Monday, September 23, 2013, the Food and Drug Administration ("FDA") released the Final Guidance on mobile medical apps.1 This Guidance brings much needed clarity for app developers who, in the past couple of years, have been creating innovative mobile apps for doctors and patients, but who were often sailing in fog when trying to determine whether their apps were regulated medical devices. The Guidance defines three types of mobile apps: (1) mobile apps that do not meet the definition of medical device and thus are not subject to FDA regulations; (2) mobile medical apps that meet the definition of a medical device and which FDA will regulate; and (3) mobile apps that meet the definition of medical devices, but will be subject to enforcement discretion because these apps pose little to no risk to patients. Perhaps the key point for industry and the public is this third category of mobile apps subject to enforcement discretion (meaning FDA will not enforce requirements under the Federal Food, Drug, and Cosmetic Act). The Guidance is clarifying FDA's approach for some types of apps that have become ubiquitous tools for patients with chronic diseases. Background In July 2011, FDA published the Draft Guidance on mobile medical apps, and began a public comment period which sub- DANIELA ("DANA") A. PIRVU is an Associate in the Health Care and Life Sciences and Corporate Services practices, in Epstein Becker & Green, P.C.'s Washington, D.C. office. sequently produced over 130 comments. Stakeholders concerns ranged from fears that phones would be regulated as medical devices to online distributors of mobile apps like "iTunes App store" would be considered a medical device "manufacturer." Others voiced frustration that it was unclear which apps FDA would or would not regulate. 20 Update November/December 2013 www.fdli.org http://www.fdli.org

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Update Nov Dec 2013