Navigating the Regulatory Grey Area of Wearables: Consumer Product or Medical Device?

As wearable technology becomes more sophisticated, many manufacturers find themselves navigating a complex regulatory environment. Those wearables that are designed originally as consumer products may inadvertently cross into the realm of medical devices when manufacturers add health-related functionality. Therefore, understanding the fine line between a consumer product and a medical device is crucial for manufacturers to ensure compliance and mitigate potential legal risks. This post is the first in a series in which we will discuss the transformation of consumer-product wearables into medical devices and the possible compliance and products liability challenges that arise under the circumstances.

The distinction between a consumer product and a medical device hinges on the intended use of the product. Under the Federal Food, Drug, and Cosmetic Act (FDCA), a medical device is defined as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is:

1. Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
2. Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
3. Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.[1]

The intended use of a product is the cornerstone of its classification. Wearable devices marketed to monitor fitness or general wellness typically fall under the jurisdiction of consumer products.[2] However, when these devices are promoted for medical purposes, such as for diagnosing or treating health conditions, they may be classified as medical devices.

A review of “How to Determine if Your Product is a Medical Device” illuminates how promotional materials suggesting that the wearable can diagnose, prevent, or treat a disease or condition are likely to push the wearable into the realm of medical devices. Also, device features that collect or analyze data in a way that is intended for medical purposes may trigger medical device classification. Lastly, directions that imply medical uses or diagnostic capabilities can also push a product into the medical device category.

It is important for manufacturers to review all marketing materials to ensure that advertising and promotional content aligns with the intended use as a consumer product. A key resource for manufacturers is the numerous FDA guidelines and policies that address this issue and potential regulatory changes. It is also advisable to engage with legal experts who specialize in FDA regulations to conduct a thorough assessment of your product’s classification.

Manufacturers of wearables must be vigilant in their product development and marketing strategies to avoid inadvertently crossing into the medical device territory. By understanding the regulatory framework and carefully assessing the intended use, manufacturers can navigate this grey area effectively, ensuring compliance and reducing the risk of legal challenges.

[1] https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

[2] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices