Hi folks.
My company is considering development of a hydrocolloid patch to be used as a protective covering over acne. There is no specific acne active ingredient as the patch works by absorbing oil and other pore clogging materials as well as any exudate that might come from the lesion such as pus. We are trying to determine the proper product code and therefore the proper product category to ensure that we do our due diligence with respect to any filings (above and beyond our current device establishment registration and device listing). We have found there is a possibility to list under product code KMF or under NAC. KMF would require 510(k) (there are plenty of predicates for us to use on this one) while NAC (provided there are no active ingredients in the product) would qualify as Class 1 and be 510(k) exempt under the circumstances.
Any thoughts on what the best code to use in this instance would be? Thanks for any help the community can provide on this one!
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Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States
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