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 Coalition submitted comments to FDA’s General & Plastic Surgery Devices Panel of the Medical Devices Advisory Committee on FDA-2016-N-2147, recommending that antimicrobial wound care dressings in the FRO category, such as solids, cream/gel/ointment and liquid washes, be classified as Class II medical devices and regulated using the 510(k) premarket notification process. The Coalition based this recommendation on the fact that antimicrobial products in the FRO category fit the safety and effectiveness standards for class II while falling short of the standards for class III. 
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