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Antimicrobial Resistance Concerns Leach into FDA's Classification of Wound Dressings Containing Drugs

15 November 2016

MD+DI

On September 20–21, 2016, FDA convened an advisory panel to seek recommendations about the regulatory classification for wound dressings containing drugs. These devices are widely used to treat medical conditions ranging from minor cuts and burns, to diabetic foot ulcers and historically have been cleared by FDA through the 510(k) process. While this is not the first time FDA has looked to experts to help evaluate the classification of wound dressings containing drugs, this panel meeting was prompted in part by evolutions in technology, the breadth of cleared indications for use, the extensive list of ingredients (many with known or potential chemical activity), and the public health implications associated with antimicrobial resistance (as evidenced by FDA's recent ban of 19 antibacterial agents in soaps).

Read More: Antimicrobial Resistance Concerns Leach into FDA's Classification of Wound Dressings Containing Drugs

Contacts

Chan Lee

Chan Lee

Director of Regulatory Sciences
Washington, D.C.

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