Article prepared by and republished courtesy of our colleagues Mary Langowski, Rebecca Jones McKnight, Kristen Ratcliff and So-Eun Lee; originally published here: http://www.dlapiper.com/offering-health-care-solutions-at-consumers-fingertips-what-you-should-know-about-fda-regulation-of-mobile-medical-apps/.

Over two years after the Food and Drug Administration issued draft guidance on “mobile medical applications,” the agency recently issued its greatly anticipated final guidance. As FDA considered comments from stakeholders during this prolonged review period, many in the industry continued to struggle with understanding the boundaries proposed by FDA and their potential impact on businesses across the health care sector.

The principles outlined in the final guidance remain consistent with those described in the draft guidance. FDA has stated that it is “not expanding [FDA’s] universe” by regulating mobile medical applications (i.e., apps), but rather applying longstanding basic tenets of medical device regulation and–at the core – requirements of the Food, Drug and Cosmetic Act (FDCA). These principles may, however, be unfamiliar to many in the technology space, particularly those who have not previously been involved with FDA-regulated devices.

In response to industry requests for clarity, FDA added a number of specific examples in the final guidance, including examples of mobile apps that would not be considered regulated devices; and those that would technically be considered devices, but to which FDA would apply enforcement discretion.

Below we provide an overview of FDA’s final guidance, including a high-level look at FDA’s intended regulatory approach.
Continue Reading What you should know about FDA regulation of mobile medical apps