FDA Seeks Feedback on Classification of Antimicrobial Wound Care Products

August 12, 2016

The FDA will hold a public meeting on Sept. 20-21 to discuss the classification of certain wound care products containing antimicrobials.

These products are regulated under product code FRO, “Dressing, Wound, Drug,” and are considered “pre-amendments” because they were in commercial distribution before the Medical Devices Amendments were enacted, and have not yet been classified.

The FDA is seeking input on the indications for use, risks to health, and safety and effectiveness of these wound care products, and how they should be classified. Some of these products may meet the definition of Class II, and some may meet the definition of Class III.

The agency is also requesting pubic comment on the risk of antimicrobial resistance in light of the increasingly significant national public health concern posed by AMR.

Interested parties may submit comments at Docket No. FDA-2016-N-2147. For information about attending, email: Evella.Washington@fda.hhs.gov.