In a final guidance document released July 29th, the U.S. Food and Drug Administration (“FDA”) officially confirmed that it does not intend to review or require regulatory compliance for fitness trackers and certain health apps, collectively termed “general wellness products.” This guidance, which is largely unchanged from the draft guidance issued in January 2015, coincides with FDA’s narrowing oversight of mobile medical apps and related tools.
According to the guidance, general wellness products are:
- Products that are intended for “general wellness use” (e.g., weight management, physical activity trackers, and stress management tools); and
- Products that present a low risk to the safety of users and others persons.
The primary distinction between a general wellness product and a medical device, which FDA does regulate, is that the intended use of a general wellness product is either to maintain or encourage a general state of health or healthy activity or to support a healthy lifestyle to help reduce the risk or impact of certain chronic conditions where there is a well-known connection. The guidance further explained that although general wellness products may claim to help manage or reduce the risk of certain chronic diseases, they may not claim to treat or diagnose a specific disease or condition. Products that make these claims are considered medical devices and are subject to FDA regulation.
As mentioned above, this guidance is in line with FDA’s recent policy to exercise enforcement discretion when dealing with products that may help consumers manage or prevent ill health and pose a minimal risk of harm. The policy attempts to strike a balance between ensuring consumer safety while supporting the rapid pace of innovation that is directed at consumer health. This guidance along with earlier guidance can help mobile medical app, fitness trackers, wellness tools, and health information technology developers determine how to market their products in light of existing law and should be considered in the early stages of product development and business strategy.
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