Regulatory Open Forum

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  • 1.  Product code listing

    Posted 29-Sep-2014 09:55
    We are reviewing all of our listing in anticipation of the upcomming registration and have a question concerning product codes. Can anyone tell me the difference between FDA product codes NEC and KMF. I have found some skin wipes that are not sterile listed under NEC even though the regulation number for both codes is 880.5090 and that regulation calls out a sterile product. Is there a separate product code for nonsterile skin protectants?

    Charles Cosner
    Regulatory Affairs Manager
    Bioderm, Inc.
    Largo FL
    United States