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 Winner Medical Co., Ltd., Huizhou Foryou Medical Devices Co., Ltd. and 3M Company.
FDA 510(k) Cleared Dressing, Wound, Drug Devices (Product Code FRO)
About Product Code FRO - Regulatory Context
510(k) Submission Activity
702 total 510(k) submissions under product code FRO since 1978, with 702 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 259 days to reach a decision - up from 184 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 →