If you manufacture wearable fitness trackers or electronic massagers, determining how your product will be regulated is an important exercise. An erroneous conclusion can have a substantial impact on your business.
At the end of July 2016, FDA published a final guidance for these types of products, titled General Wellness: Policy for Low Risk Devices. The guidance focuses on the analysis that should be employed when determining if a product falls into this general wellness product category, and states that the Agency will neither examine general wellness products to determine if they are “devices,” nor evaluate them to determine compliance with other FDA regulation.
What are General Wellness Products?
General wellness products are products that are intended only for general wellness uses – i.e. maintaining or encouraging health, or using a healthy lifestyle to reduce the impact of certain chronic diseases – and that present a low safety risk by not being invasive or implanted and not requiring specific regulatory controls.
What Claims can be made with a General Wellness Product?
General wellness products can make claims which relate to sustaining, or offering general improvement of, functions associated with general health. These claims can only reference those diseases or conditions where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition.
Claims in the general wellness category typically deal with weight management, physical fitness, relaxation or stress management.
While this guidance provides a good starting point for evaluating products, it does not carry the force of law and the Agency retains substantial discretion in its application. We often encounter clients who meet the requirement of the guidance, but face strict enforcement decisions from the Agency. Contact us today for help with medical device claims.
