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

In January 2015, the FDA released its draft guidance on general wellness products, a reassuring indication that the FDA will focus its efforts on regulating higher risk products rather than products that present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. To better understand this guidance, Worrell collaborated with medical device compliance expert Sarah diFrancesca, an associate in the Health Care & Life Sciences Regulatory group at Cooley LLP.

In its draft guidance, the FDA states that it will not regulate general wellness products that: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/or 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.

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