Citation[]
Food and Drug Administration, General Wellness: Policy for Low Risk Devices (Draft Guidance for Industry and Food and Drug Administration Staff) (Jan. 20, 2015) (full-text).
Overview[]
This guidance provides clarity to industry and FDA staff on the Center for Devices and Radiological Health's (CDRH's) compliance policy for low-risk products that promote a healthy lifestyle (general wellness products). This guidance does not apply to products (e.g., drugs, biologics, dietary supplements, foods, or cosmetics) regulated by other FDA Centers or to combination products, including those regulated by CDRH.