FDA Issues Draft Wellness Device Guidance

(FitBit Inc.)

19 January 2015. The U.S. Food and Drug Administration on Friday released draft guidance defining low-risk general wellness devices that the agency intends to exclude from regulatory oversight. The 8-page document, published on the FDA Web site, will be open for comment for 90 days beginning tomorrow.

FDA says it prepared the document to answers questions about the applicability of the Federal Food, Drug, and Cosmetic Act to new products for general health and wellness. The products include exercise equipment, audio recordings, video games, and software programs, many of which are sold through retailers or available for download.

The agency defines a general wellness product as one having an intended use that:

1. Relates to maintaining or encouraging a general state of health or a healthy activity, or

2. Associates 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.

The first part of the definition covers products that offer general improvement to conditions or functions associated with a general state of health. FDA points out that “general state of health” means the product makes no reference to specific diseases or conditions.

Examples of products covered under general wellness are those for weight management, sleep management, relaxation, self-esteem, and sexual function. Products not covered by the definition, and thus subject to oversight, are those that treat specific disorders such as obesity or anxiety, or diagnose conditions such as autism.

Products covered under the second part of the definition — associating healthy lifestyles with less risk or management of chronic diseases — are those that help individuals encourage or track behaviors that reduce the risk of contracting chronic disorders, such as heart disease and diabetes, as well as help individual live with these disorders. Claims made by these products should be well understood and supported by evidence.

Examples of products covered under the second part of the definition are those promoting exercise to reduce the risk of high blood pressure and software tracking caloric intake for maintaining a healthy weight to live with diabetes.

The document defines as well products and devices it consider low-risk, using factors such as invasiveness, impact on user safety, or involve questions of usability or biocompatibility. Examples covered under this definition of low-risk are music to sooth and relax the listener to help manage stress, and activity trackers that raise awareness of the user’s exercise to improve to maintain cardiovascular health.

Example not considered low-risk, and thus subject to regulatory oversight, are sun lamps for tanning and laser products to rejuvenate skin, since laser technology poses risks of burns to eyes and skin.

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