FDA Declares ‘General Wellness’ Devices Exempt From Regulations

Regulatory NewsRegulatory News | 28 July 2016 |  By 

The US Food and Drug Administration (FDA) on Thursday finalized guidance saying that it does not plan to review low-risk "general wellness products", such as wearable fitness monitors or sleep trackers and will not require them to comply with premarket and postmarket regulatory requirements.

Under the guidance, such products are exempt as long as they "are intended for only general wellness use…and present a low risk to the safety of users and other persons."

As in the draft guidance, FDA defines general wellness products to be those with:

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

With these definitions, FDA has kept in line with its previous guidance on other health and wellness products, such as mobile medical applications and exercise equipment, where depending on the product's intended use, it could fall under FDA regulations.

Under the first category, a manufacturer would not be able to make any specific claims about their products’ ability to impact diseases or conditions. For example, FDA says manufacturers could say their product can be used to help with weight management but may not claim the product can treat or diagnose obesity.

However, as FDA Law Blog pointed out in their coverage of the draft guidance last year, the second category appears to give manufacturers some leeway to make specific references to diseases or conditions while remaining outside FDA's purview:

"The significance of this is that the manufacturer may say more about the product than it merely helps achieve a healthy lifestyle or may help aid in weight loss. It can then link those outcomes to potential benefits with specific disease states, implying that the product itself may, to a certain extent, help mitigate or reduce the risk of those disease states."

In this category, FDA says manufacturers could say their product is intended "to promote, track, and/or encourage choice(s), which as part of a healthy lifestyle, may help to reduce the risk of [or may help living well with] certain chronic diseases and conditions."

For example, FDA says a manufacturer could market a product that promotes physical activity and make the claim that the product "may help reduce the risk of high blood pressure."



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