FDA Product Code FRO: Dressing, Wound, Drug
FDA product code FRO covers drug-eluting wound dressings that combine a wound contact layer with an active pharmaceutical ingredient.
These dressings deliver antimicrobial agents, growth factors, or analgesics directly to the wound bed while maintaining a moist healing environment. The drug component provides local therapeutic activity beyond the mechanical protection of a standard dressing.
FRO devices are reviewed by the FDA General & Plastic Surgery panel.
Leading manufacturers include Convatec, A Division of E.R. Squibb & Sons, Winner Medical Co., Ltd. and Huizhou Foryou Medical Devices Co., Ltd..
FDA 510(k) Cleared Dressing, Wound, Drug Devices (Product Code FRO)
About Product Code FRO - Regulatory Context
510(k) Submission Activity
705 total 510(k) submissions under product code FRO since 1978, with 705 receiving FDA clearance (average review time: 187 days).
Submission volume has remained relatively stable over the observed period, with 35 submissions in the last 24 months.
FDA 510(k) Review Time - FRO Product Code
Recent submissions under FRO have taken an average of 239 days to reach a decision - up from 185 days historically. Manufacturers should account for longer review timelines in current project planning.
FRO devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →