Fandom

The IT Law Wiki

General Wellness: Policy for Low Risk Devices

32,189pages on
this wiki
Add New Page
Talk0 Share

Ad blocker interference detected!


Wikia is a free-to-use site that makes money from advertising. We have a modified experience for viewers using ad blockers

Wikia is not accessible if you’ve made further modifications. Remove the custom ad blocker rule(s) and the page will load as expected.

Citation Edit

Food and Drug Administration, General Wellness: Policy for Low Risk Devices (Draft Guidance for Industry and Food and Drug Administration Staff) (Jan. 20, 2015) (full-text).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 Edit

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.

Also on Fandom

Random Wiki