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 Huizhou Foryou Medical Devices Co., Ltd., Winner Medical Co., Ltd. and Kane Biotech, Inc..
FDA 510(k) Cleared Dressing, Wound, Drug Devices (Product Code FRO)
About Product Code FRO - Regulatory Context
510(k) Submission Activity
701 total 510(k) submissions under product code FRO since 1978, with 701 receiving FDA clearance (average review time: 188 days).
Submission volume has increased in recent years - 39 submissions in the last 24 months compared to 28 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FRO have taken an average of 260 days to reach a decision - up from 183 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 →