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General Wellness Devices & Wearables: Regulatory Options You Need To Know

Most medical device companies take their products to FDA prior to marketing. But is there a way to legally market a medical device without taking it to FDA first?

Maybe! The “general wellness exemption” provides a way to legally market certain medical devices without FDA clearance or approval.

Is this a new idea? Absolutely not! Companies having been doing this for decades; however, some companies have gotten in trouble for doing so improperly.

To help, FDA issued the General Wellness: Policy for Low Risk Devices guidance here. Despite this guidance, many companies still struggle with understanding which devices qualify under the wellness exemption and what documentation is necessary to support such a claim.

In addition, many companies don’t realize that the same device may be marketed as both a wellness device and as a 510k, de novo or even PMA at the same time. In fact, the wellness exemption offers an opportunity for label expansions to FDA regulated devices in the future.

When used effectively, the general wellness exemption offers significant advantages in to market sooner. But if not used properly, the wellness exemption can significantly increase the regulatory risk of punitive action.