FDA plans advisory panel meeting on antimicrobial dressings

The FDA last week announced plans to hold an advisory panel meeting to cover the classification of wound care products containing antimicrobials and other drugs.

The panel is slated to meet in Washington D.C. on September 20 and 21, according to a release from the federal watchdog.

The FDA is seeking input on the indications for use, risks to health and safety and effectiveness of the antimicrobial wound care products, as well as which class the products should be placed into.

The federal watchdog said that some of the products may “meet the definition of class II,” while other products “may meet the definition of class III in light of their intended use, composition, the extent of clinical benefit, and the risks they pose,” according to the release.

The agency will discuss the use of antibiotics in the products, and the risk of antimicrobial resistance “in light of the increasingly significant national public health concern posed by AMR.”

The FDA said it will make background material on the matter available to the public at least 2 days before the meeting.

Earlier this month, the FDA released draft guidance providing updated recommendations for manufacturers on when to submit 510(k) applications for modifications to devices currently on the market.

The recommendations cover how manufacturers should consider the risk of device modifications when determining whether they need to submit a new 510(k) application, and will replace guidance that is 19 years old.

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