FDA Draft Guidance on General Wellness Devices: A Primer
Last month, the FDA's Center for Devices and Radiological Health (CDRH) released draft guidance on general wellness products, including wearables. The guidance outlines a framework and includes an algorithm for classifying general wellness products and which devices the FDA will regulate.
General Wellness: Policy for Low Risk Devices states that the FDA does not intend to regulate low-risk general wellness products, which includes wearables such as the Nike Fuelband and Fitbits as well as apps like MyFitnessPal and MapMyRun. The guidance classifies low-risk general wellness products as products that are intended for only general wellness use and that present a very low risk to users' safety. General wellness products may include exercise equipment, audio recordings, video games, software programs and other products that are commonly, though not exclusively, available from retail establishments (including online retailers and distributors that offer software to be directly downloaded).
The guidance further states that general wellness products can only make claims about sustaining or offering general improvement to conditions and functions associated with a general state of health and must not make any claims about specific diseases or conditions. Appropriate general wellness claims include:
- Weight management
- Physical fitness, including products intended for recreational use
- Relaxation or stress management
- Mental acuity
- Sleep management
- Sexual function
The FDA also defines intended use for general wellness products as:
- Promoting, tracking, and/or encouraging choice(s), which, as part of a healthy lifestyle, may help to reduce the risk of certain chronic diseases or conditions; and
- Promoting, tracking, and/or encouraging choice(s) which, as part of a healthy lifestyle, may help living well with certain chronic diseases or conditions.
Examples of chronic diseases for which a healthy lifestyle is associated with risk reduction or help in living well include heart disease, high blood pressure, and type 2 diabetes.
The guidance shows that the FDA is mainly concerned with products making specific medical claims. It makes the distinction that the FDA is not approving general wellness devices; it just isn't regulating them. In that vein, wearables now fall into the same category as vitamins and supplements.
To that same point, the FDA is unconcerned about whether these low-risk products do what they claim to do. That doesn't mean, however, that pharma can dismiss this guidance.
Implications for pharma
The guidance is a good starting point: it tells us where the line is and that we can focus on low-risk devices without arousing FDA oversight. That said, we might need to decouple general wellness data with specific health-related data (blood pressure, glucose levels) so that apps don't cross the general wellness/specific disease or condition line. Additionally, we are seeing more devices coming onto the market that target specific conditions and patient populations, indicating a move from basic monitoring to actual treatment. As this continues, the FDA will have to revise its guidance on such products.
The FDA has historically taken this path with its guidance on social media. It hasn't issued strict policy on social media, only draft guidance. It has updated this guidance as social media has matured and gained traction in the pharma space, and it will need to take the same approach as wearables and other low-risk devices continue to enter the space.
We need to use our clout as pharmaceutical marketers and app developers to influence future FDA guidance on general wellness devices. We understand the technology, its intended use and the regulations of the industry, so we should educate the market and shape the landscape so that pharma will continue uptake of these devices in a smart, FDA-compliant manner.Martha Walz is a content strategist at Ogilvy CommonHealth.