The Food and Drug Administration (FDA) released a final guidance on July 29, 2016, saying that it does not plan to require pre-market review for low-risk "general wellness products," such as wearable fitness monitors, pedometers and sleep trackers. This guidance is a continuation of a notice of availability published in the Federal Register January 20, 2015, entitled "General Wellness: Policy for Low Risk Devices: Draft Guidance for Industry and Food and Drug Administration Staff."
The final guidance defines general wellness products as "products intended for only general wellness use … and [those that] present a low risk to the safety of users and other persons." Products such as these encourage or help maintain a general state of health or link a healthy lifestyle with helping to reduce the risk of certain chronic conditions. Importantly, these devices may not make any reference to specific diseases or conditions. In this way, general wellness apps, wearables and other devices will receive regulatory treatment similar to that of dietary supplements.
To be considered a "low-risk" general wellness product, devices must:
- Not be invasive (penetrating or piercing the skin or mucous membranes);
- Not be implanted; or
- Not involve an intervention or technology that may pose risk to the safety of users or other persons if specific regulatory controls are not applied.
The FDA was quick to point out that being considered a general wellness product does not establish the product's safety or efficacy for its intended use.
In short, general wellness products will not be treated as medical devices (or drugs, for that matter) and thus will not be subject to substantial regulatory review. Specifically, for general wellness products, the Center for Devices and Radiological Health (CDRH) will not:
- Examine them to determine whether they fit the "device" definition under the Federal Food, Drug and Cosmetic Act (FD&C Act);
- Examine them for compliance with the premarket review and post-market regulatory requirements for devices; and
- Require them to uphold registration, listing, labeling and various other premarket notification requirements.
The guidance does not go into detail regarding additional restrictions and requirements for devices used beyond the above definition, so open questions remain:
- Does the characterization of the device change if used for research purposes or in a clinical trial?
- How closely will FDA monitor whether products are making general wellness claims, and what will FDA do if/when a product crosses the line into disease claims?
- Will the FDA be compiling an open-source database of all general wellness products and their claims, similar to that of the NIH's database for dietary supplement labels?
- And while this guidance squarely addresses devices, it begs the question about whether websites that offer the same or similar features as a general wellness product should receive similar regulatory treatment.
The digital health team at Faegre Baker Daniels Consulting and Faegre Baker Daniels will be tracking (no pun intended) these issues. Look for additional updates from us as companies, consumers and FDA put this final guidance into practice.