General Wellness: Policy for Low Risk Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

Samenvatting

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "General Wellness: Policy for Low Risk Devices." The guidance is intended to provide clarity to industry and FDA staff on Center for Devices and Radiological Health's (CDRH) compliance policy for low-risk products that promote a healthy lifestyle (general wellness products). By clarifying the policy on general wellness products, we hope to improve the predictability, consistency, and transparency on CDRH's regulation of these products. For purposes of the guidance, CDRH defines "general wellness products" as products which meet the following factors: They are intended for only general wellness use as defined in the guidance and present a low risk to the safety of users and other persons.