05.08.2016

FDA: Guidance on Low Risk (General Wellness) Devices

FDA, General Wellness: Policy for Low Risk Devices (pdf):
The Food and Drug Administration (FDA) is issuing this guidance document to provide 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. [...]