The Food and Drug Administration Safety Innovation Act of 2012 (“FDASIA”) required a collaborative effort by the Food and Drug Administration (“FDA”), Federal Communications Commission and Office of the National Coordinator for Health Information Technology to provide a proposed strategy and recommendations for an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications and other software products, that promotes innovation, protects patient safety, and avoids regulatory duplication. In response to the FDASIA, the three agencies issued the FDASIA Health IT Report (“Health IT Report”) on April 3, 2014. As part of the Health IT Report, FDA indicated it would provide clarification regarding the distinction between wellness and disease-related medical device claims. FDA’s clarification on this point came in January 2015, when the draft guidance on “General Wellness: Policy for Low-Risk Devices" (the “Draft Guidance”) was issued, describing wellness devices for which the agency would not enforce oversight due to sufficiently low risk. This guidance was recently finalized on July 29, 2016 (the “Final Guidance”). FDA has also attempted to clarify its digital health policies through other guidance on mobile medical applications, medical device data systems, and medical device accessories, and further guidance is expected on clinical decision support tools in connection with the same. This client alert (“Alert”): (1) summarizes the Final Guidance, (2) highlights the differences between the Final and Draft Guidance, which provide additional insight to FDA’s thinking in this area, and (3) discusses implications of the guidance for industry.

1. FINAL GUIDANCE SUMMARY -

Manufacturers of products intended for general health and wellness have historically struggled with determining whether they are subject to FDA regulation. The ambiguity is typically caused by the definition of “device” in section 201(h) of the Food, Drug & Cosmetic Act triggering FDA oversight, which includes products intended to be used for “the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man … or intended to affect the structure or any function of the body of man....”