Safe Prediction for 2013: Significant Expansion of Mobile App Regulation (FDA and COPPA)
The Food and Drug Administration (FDA) has announced its priority list of medical device guidance documents for Fiscal Year 2013 (October 1, 2012 thru September 30, 2013). FDA's list includes final guidance on Mobile Medical Applications as an "A List" priority for 2013. On July 21, 2011, FDA issued draft guidance which would require many mobile apps "intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease" to go through pre-market approval by the FDA as a medical device. Regardless of where the FDA elects to draw the line between that which constitutes a regulated Mobile Medical App and that which does not in the final guidance, the agency action on the matter will nevertheless mark an expansion of federal authority over the mobile app ecosystem.
An analogous expansion of federal authority is underway with respect to the Children's Online Privacy Protection Act (COPPA) with a finalized privacy rule under COPPA expected by the end of 2012 or thereabouts. The trend seems pretty clear.