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August 2, 2016

FDA Finalizes Guidance on Low Risk General Wellness Devices

Digital Health Download

On July 29, 2016, the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) finalized a guidance framing its enforcement discretion policy regarding Low Risk General Wellness Devices. The Final Guidance largely tracks the draft policy issued in January 2015 (which we previously summarized), but provides more insight into FDA's thinking, as well as additional examples of products falling within and outside the terms of FDA enforcement discretion.

Under the Final Guidance, CDRH does not intend to examine low risk "general wellness products" (as defined in the Final Guidance) to determine whether they are medical devices within the meaning of the Federal Food, Drug, and Cosmetic Act (FDCA), and if they are devices, whether they comply with the pre-market review and post-market regulatory requirements for devices under the FDCA and implementing regulations (e.g., 21 CFR Part 807 (premarket notification); 21 CFR Part 801 and 21 CFR § 809.10 (labeling); 21 CFR Part 820 (good manufacturing practices/Quality Systems); and 21 CFR Part 803 (Medical Device Reporting (MDR) requirements)).

In other words, CDRH does not intend to actively regulate products that meet the definitions in the Final Guidance, regardless of whether the product would otherwise meet the definition of a medical device under section 201(h) of the FDCA. The Final Guidance does not apply to any products regulated by FDA's other Centers (e.g., drugs, biologics), or to combination products.

CDRH did, however, make several clarifications in the Final Guidance and provided additional examples that may be useful for industry in assessing the regulatory status of devices, as described in greater detail below. CDRH also announced that it will be holding a Webinar on September 1, 2016, to discuss the Final Guidance.

To read more about the Final Guidance, please read our Advisory.