Mobile App Developers May Benefit from FDA's Draft "Wellness" Guidance Proposing Not to Regulate Some Low Risk Medical Devices


On January 16, 2015, the FDA released a draft guidance on "General Wellness: Policy for Low Risk Devices" that proposes a novel rationale for not regulating what might otherwise be considered medical devices.

The traditional way of avoiding FDA device regulation is not to make claims that a product is intended for the diagnosis of a disease or condition, nor for the cure, mitigation, treatment, or prevention of disease. The FDA's draft guidance recognizes that products that do not make such claims are likely not devices.

In a new twist, the draft guidance document proposes another category of unregulated "wellness" products that are intended to promote, track, and/or encourage personal choices that may help to (i) reduce the risk of or (ii) help live well with certain chronic diseases or conditions. Such claims may refer to specific diseases or conditions only when it is well understood and generally accepted (e.g. described in peer-reviewed scientific publications) that healthy choices may reduce the risk or impact of a chronic disease or condition. What constitutes a "peer-reviewed scientific publication" or other evidence of being well understood and generally accepted may be a matter of some debate.

This approach is similar to the FDA's regulation of "structure/function" claims for dietary supplements, which must be substantiated with valid scientific evidence. Such claims typically refer to maintaining healthy structure or function of the body or general well-being.

Whether the FDA ultimately adopts this approach for not regulating certain low risk medical devices in a final guidance or rulemaking remains to be seen, but the proposal represents a potentially exciting new development in the regulation (or lack thereof) of medical devices, particularly mobile apps that are designed to provide people with real-time information to make well-informed choices that may affect their health.

The draft guidance is available here. Public comments must be made within 90 days of publication in the Federal Register (by approximately mid-April).