FDA cosmetic vs. device classification — one written answer needed

Posted 4 weeks ago

Worldwide

Summary

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
  • Intermediate
    Experience Level
  • Remote Job
  • One-time project
    Project Type
Skills and Expertise
Mandatory skills
Legal
Legal Consulting
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
Member since Jun 21, 2026
  • Morocco
    6:31 AM
  • Legal
    Individual client

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