Panel to Discuss Wound Care Product Dressing

Federal Register Notice: FDA will hold a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee 9/20-21, from 8 a.m. to 6 p.m. at Hilton Washington, DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss and make recommendations on the classification of certain wound care products containing antimicrobials and other drugs as part of the routine process for device classification. These products are regulated under product code FRO, “Dressing, Wound, Drug,” and are considered “pre-amendments” because they were in commercial distribution prior to 5/28/76, when the Medical Devices Amendments were enacted, and have not yet been classified under section 513 of the Federal Food, Drug, and Cosmetic Act. Contact Evella Washington, (301) 796-6683, Evella.Washington@fda.hhs.gov. To view this notice, click here.