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GUIDANCE DOCUMENT

General Wellness: Policy for Low Risk Devices Guidance for Industry and Food and Drug Administration Staff July 2016

Final

General Wellness: Policy for Low Risk Devices

Docket Number:
FDA-2014-N-1039
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-N-1039.