The FDA has issued a final guidance on low risk wellness devices, and it is refreshingly clear. Rather than applying regulatory discretion as we have seen in the medical app space, the agency has made a broader decision (all usual caveats about non-binding guidances aside) not to even examine large swathes of wellness products to determine whether they are Section 201(h) devices. As such, this guidance more closely resembles the 2013 guidance that declared Personal Sound Amplification Products (PSAPs) not to be medical devices (aka hearing aids).
The FDA approach to defining excluded products breaks no new ground. First, they must be intended for only general wellness use and, second, present a low risk. As to the former, FDA has evolved its approach to referencing specific diseases or conditions. Make no such reference and your product will sail through as a general wellness product. Thus, claims to promote relaxation, to boost self-esteem, to manage sleep patterns, etc., are clearly exempt. On the other hand, the agency will clearly regulate products that claim to treat or diagnose specific conditions.
However, not all references to diseases or conditions are contraindicated. Manufacturers are offered two exceptions. First, if the intended uses are “to promote, track, and/or encourage choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions.” Second, if the intended uses are “to promote, track, and/or encourage choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.” A device that promotes physical activity and so may reduce the risk of high blood pressure would be an example of the former “risk reduction” type. A product that promotes sleep and a balanced diet to help manage type 2 diabetes would be an example of a “living well” or disease management product.
The “low risk” determination is based partly on primarily objective criteria (the product is neither invasive nor implanted) but also involves an inquiry into a product’s overall risk profile and recommends consideration of the regulatory status of similar products. The low-risk examples given in the guidance cover most familiar wellness products, including those that manage stress, monitor energy use, record food consumption, and monitor pulse rates.
The guidance even ends with a decision tree-like section to help manufacturers. No doubt an online version such as the FTC/FDA/OCR Mobile Health Apps Interactive Tool will be forthcoming!
It will be interesting to see if this (primarily) hardware product guidance foreshadows some reevaluation of the (primarily) software Mobile Medical Applications guidance. Clearly, they are interrelated. For example, an app that might have been considered a device because it provided the readout for a wellness device likely no longer is because the latter is no longer considered a “device.” More broadly, however, a new guidance on mobile apps would be welcome if it, too, bright-lined that space.
Finally, of course, it is important to note that these guidances only relate to product safety. However, hardware and software wellness products pose far greater risks to their users’ privacy and security. As OCR recently reminded us in a report to Congress, “mHealth technology used by individuals to manage their own health, but not offered or provided to the individual by a covered entity or business associate, is outside of HIPAA’s scope.”