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Wellness Device Labeling Guidelines and question

R

RAbsurd

#1
We manufacture mostly FDA cleared devices and are a FDA registered establishment as well as ISO 13485 certified. We are launching several "wellness" devices that really do meet The FDA Draft guidance on General Wellness Devices criteria. Sales has asked me for a labeling guideline. I don't want to use 21CFR 801. Does anyone have a suggestion? The web is failing me!
:thanks:
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
We manufacture mostly FDA cleared devices and are a FDA registered establishment as well as ISO 13485 certified. We are launching several "wellness" devices that really do meet The FDA Draft guidance on General Wellness Devices criteria. Sales has asked me for a labeling guideline. I don't want to use 21CFR 801. Does anyone have a suggestion? The web is failing me!
:thanks:
That guidance suggests that if not a medical device under FDA's oversight, a general wellness product might be considered a "consumer product", under the CPSC's authority.

Where can I get additional information?
For more information on the requirements for product and outer package labeling, contact the U.S. Consumer Product Safety Commission:
Office of Compliance (for specific enforcement inquires): e-mail: [email protected]; telephone: (301) 504-7520.
Small Business Ombudsman (for general assistance understanding and complying with CPSC regulations): e-mail: Please use our Contact Form, which is the best way to get a fast response; telephone: (888) 531-9070.
 
R

RAbsurd

#3
Thank you so much! I tried the Federal Trade Commission but never thought of the CPSC. I've been blinded by regulators!:thanx:
 
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