General Wellness Products: Will the FDA Regulate Your Medical App or Device?

FDA General Wellness Banner

In January 2015, the U.S. Food and Drug Administration (FDA) released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than products that present a low risk to users. Cooley recently collaborated with Worrell to develop the algorithm below to help companies determine whether their product may qualify as a general wellness product.

In its draft guidance, the FDA states that it will not regulate general wellness products that:
  1. Are intended only for general use, and
  2. Present a very low risk to users’ safety.

According to the FDA’s definition, a “general wellness product” has:

  1. An intended use that relates to maintaining or encouraging a general state of health or a healthy lifestyle, or
  2. An intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions, where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

In other words, if your product’s intended use is not limited to the above general wellness intended uses and it does not present a very low risk to users’ safety, the product is outside the FDA’s scope of guidance related to general wellness products.

1 Comment

Filed under FDA Draft Guidance, Health IT, Medical Devices

One response to “General Wellness Products: Will the FDA Regulate Your Medical App or Device?

  1. Pingback: All is Well:  FDA to Host Webinar on its Final Guidance for Low-Risk General Wellness Devices on September 1, 2016 | TheBeat @ CooleyHealth

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