Comments

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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Comments to FDA’s General and Plastic Surgery Panel of the Medical Devices Advisory Committee for its Sept. 20-21 Meeting

The Coalition submitted comments to the FDA’s General and Plastic Surgery Panel of the Medical Devices Advisory Committee on FDA-2016-N-2147, stating that FRO products in the class II category should require 510(k) clearance and special controls to ensure their safety and effectiveness. The Coalition also advocated for the FDA establishing sub-categories within the FRO classification, outlining what these categories may include. Finally, the Coalition recommended a re-establishment of the safety and efficacy of products in the FRO category. 
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Summary of Coalition comments at CMS HCPCS public meeting

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