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., Convatec, A Division of E.R. Squibb & Sons and Derma Sciences, Inc..
FDA 510(k) Cleared Dressing, Wound, Drug Devices (Product Code FRO)
About Product Code FRO - Regulatory Context
510(k) Submission Activity
710 total 510(k) submissions under product code FRO since 1978, with 710 receiving FDA clearance (average review time: 188 days).
Submission volume has declined in recent years - 32 submissions in the last 24 months compared to 41 in the prior period.
FDA 510(k) Review Time - FRO Product Code
FDA review times for FRO submissions have been consistent, averaging 196 days recently vs 187 days historically.
FRO devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →