November 21, 2016
The Alliance submitted detailed comments advocating that solid wound dressings combined with drugs that are formulated as cream, gel, or ointment, should be classified as Class II with special controls, following FDA's Sept. 16, 2016 advisory committee meeting on the issue. The Alliance also expressed its agreement with the FDA's use of multiple product classification categories for antimicrobial products currently regulated in the FRO category (i.e., solids, cream/gel/ointment and liquid washes). The Alliance clarified that the wound care products in the FRO category containing such items as silver, PHMB, Cadexomer iodine and honey under discussion at the Panel meeting should be categorized as antiseptics and do not appear to contribute to antibiotic resistance. These comments build on the previous comment the Alliance submitted in advance of the September FDA panel meeting, and clarify that antimicrobial wound care dressings are not intended to treat or heal the wound. Instead the specific claims made in the labeling for these products include: maintain a moist wound environment, covers and protects the wounds, provides a barrier to penetration of microbes to the wound, which may reduce the risk of infection, etc.

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