FDA cosmetic vs. device classification — one written answer needed
Worldwide
Product: a non-medicated cooling hydrogel patch — water and a gel-forming polymer only, no menthol, no active ingredients — applied to the forehead/temple for comfort. Marketing plan: positioned strictly as a relaxation/self-care ritual ("cooling comfort after a long day, screen time, or studying"), with NO treatment/cure/"relieves [condition]" language, and a clear "not a medical device, for relaxation purposes only" disclaimer on packaging. Question: Given this exact formulation and marketing approach, can this product realistically stay classified as a cosmetic rather than a Class I medical device — avoiding the FDA's device establishment registration fee? What exact wording do I need on packaging/marketing to stay safely in the cosmetic category?
$10.00
Fixed-price- IntermediateExperience Level
- Remote Job
- One-time projectProject Type
Skills and Expertise
Activity on this job
- Proposals:Less than 5
- Last viewed by client:4 weeks ago
- Interviewing:1
- Invites sent:3
- Unanswered invites:2
About the client
- Morocco6:31 AM
- LegalIndividual client
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