Offering healthcare solutions at consumers' fingertips? What you should know about FDA regulation of mobile medical apps

By Mary B Langowski, Rebecca Jones McKnight, Kristen E Ratcliff and So-Eun Lee

More than two years after the Food and Drug Administration (FDA) issued draft guidance on ‘mobile medical applications’, the agency recently issued its greatly anticipated final guidance.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

The principles outlined in the final guidance remain consistent with those described in the draft guidance. The FDA has stated that it is ‘not expanding [the 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 the FDA would apply enforcement discretion…

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