The passage of the 21st Century Cures Act (“Act”) on December 7, 2016 by the 114th Congress affects many aspects of the regulatory program for Mobile Medical and General Wellness Apps planned by the U.S. Food and Drug Administration (“FDA”). Section 3060 of the Act amends § 520 of the Federal Food, Drug, and Cosmetic Act (“FDCA”) by the addition of subsection (o). New § 520(o)(1)(B) and (C) effectively removes General Wellness Apps and many Mobile Medical Apps from the jurisdiction of the FDA. Among other things, § 520(o)(3)(A), the agency must issue a final order through notice and comment rule-making to designate a Mobile Medical App or other health-related app as a device subject to the FDCA. The app must be “reasonably likely to have an adverse health consequence.”
Before this enactment, and based on the FDA’s statutory construction, General Wellness and low risk Mobile Medical Apps that monitor or collect data on human conditions or disease were defined as devices subject to the FDCA (“medical devices”). To that end, in a series of recent Guidance for Industry notices, the FDA had planned a compliance program based on three sub-categories of medical devices:
- General use apps that might be used in a health setting, including providing access to medical references, were not to be medical devices under the medical device definition.
- General Wellness Apps intended to collect or monitor data designed for use in “maintaining or encouraging health” or helping to reduce risk of disease through monitoring “healthy lifestyle” parameters, even as applied to otherwise healthy persons were in many cases medical devices, although subject to enforcement discretion under the compliance program.
- Mobile Medical Apps intended to aid specific patients in managing their illness were also deemed to be medical devices in large part. Low risk Mobile Medical Apps were subject to enforcement discretion. Determination of level of risk would be made by the sponsor, potentially putting the sponsor at risk for an erroneous decision.
Under the FDA’s planned compliance program, self-designated low risk Mobile Medical Apps and potentially regulated General Wellness apps were to be subject to FDA’s enforcement discretion policy pursuant to which the agency would defer any potential active regulation. However, the Mobile Medical Apps guidance did strongly recommend sponsor compliance with relevant parts of the Quality System Regulation for design and development where the app was a medical device even if it were subject to enforcement discretion. Design controls for standalone software would include assessment of the performance and clinical effectiveness before launch.
Under the new legislation, General Wellness apps, among others, are excluded from the scope of the FDA jurisdiction. Further, the burden of determining risk for Mobile Medical apps has been shifted to the FDA. Until the agency issues a final order, Mobile Medical and General Wellness Apps will be exempt from regulations issued pursuant to the FDCA as non-devices.