Submitted Comments

Items Related to Antimicrobials

November 21, 2016

Comments to FDA's General & Plastic Surgery Devices Panel of the Medical Devices Advisory Committee supporting classification of antimicrobial wound care products as Class II with special controls.

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. 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. Comments clarified 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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September 1, 2016

Comments to FDA's General and Plastic Surgery Panel of the Medical Devices Advisory Committee

The Alliance submitted comments to the FDA's General and Plastic Surgery Panel of the Medical Devices Advisory Committee in advance of the panel's September 2016 meeting. The Alliance emphasized that the products that are currently in the FRO category are low to moderate risk, have been in the marketplace for many years, and should be classified by the FDA into either Class I or Class II, most remaining subject to 510(k). The Alliance comments gave perspective on the issue, addressing the following:
  • An overview of wound care relating to the FRO product category
  • The science behind management of chronic wounds
  • Management of chronic wounds using antimicrobial wound care products
  • Products classified in the FRO product category, their indications for use and testing
  • Evidence for safety and effectiveness of products in FRO category/ Low-moderate risk of antimicrobial resistance
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