FDA Exempts Low-Risk Wellness Devices From Regulation

The FDA has determined that low-risk general wellness devices that promote a healthy lifestyle will be exempt from regulation.

CDRH defines wellness devices as products that are intended for only general wellness use, as defined in final guidance released July 28.

The final guidance remains little changed from draft guidance released on Jan. 20, 2015. The biggest change is in section six of the guidance, which presents a decision algorithm for determining whether general wellness products are within the scope of the guidance. — Tamra Sami