By Chuck Seegert, Ph.D.
The FDA recently released draft guidance related to products that promote a healthy lifestyle. The guidelines were released to clarify what low-risk devices fit into the category of “general wellness products.” The document was only released to elicit comments, and is not final or in effect at this time.
The fitness and general wellness industries are exploding with devices and applications designed to promote a healthy lifestyle. Smartphone apps that track mileage and count calories are freely available, and are becoming more sophisticated every day. Biometric devices for monitoring heartrate during fitness-related activities are also becoming more prevalent. As technology continues to proliferate in this area, it is natural for questions about regulation to arise.
To address these regulatory questions, the U.S. Food and Drug Administration (FDA) recently released draft guidance titled, “General Wellness: Policy for Low Risk Devices,” according to a notice in the Federal Register.
Traditionally, products considered medical devices must be approved by the FDA, establish substantial equivalence to an existing device, or comply with general design controls (like surgical gloves). The new draft guidance document, however, states that the agency does not intend to examine low-risk general wellness products to determine if they will fall within the purview of the Federal Food, Drug, and Cosmetic Act.
The agency has provided two criteria to determine if a device is classified as a “general wellness product.”
- The product is intended for only general wellness as defined in the guidance document.
- The product presents a very low risk to users’ safety.
The parameters of the guidance only extend to products with one of the following intended uses:
- A device that has an intended use related to maintaining or encouraging a general state of health or healthy activity.
- Alternatively, the intended use claim may focus on reducing the risk or impact of chronic diseases or conditions, where it is well accepted that lifestyle has a significant role in healthy outcomes.
Examples of general wellness products include exercise equipment, video games, and software programs that are commonly available through retailers, among others.
In addition to the definition of general wellness products, the guidance document provides a definition of what low risk means. Generally, if a device is invasive or involves an intervention that would cause risk to users if regulatory controls were not applied (lasers, radiation, implants, etc.), it is not defined as a low-risk device. Additionally, if the device raises novel questions of usability or biocompatibility, it is not considered low-risk.