September 1, 2016
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 product 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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