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