Pharmaceutical-Impregnated Bandages & Medical Dressings

FDA applies a primary mode of action test: if the pharmaceutical ingredient provides the primary therapeutic effect, the product is regulated as a drug (or combination product with drug lead); if the physical structure of the dressing is primary and the coating is secondary, it may be regulated as a device. This determination drives which premarket submission — NDA, 510(k), or PMA — is required, and importers should seek an FDA combination product designation if the classification is unclear.

No. Veterinary-use pharmaceutical dressings are regulated by FDA's Center for Veterinary Medicine (CVM) rather than CDER or CDRH. The applicable approval or clearance pathway, labeling requirements, and establishment registration obligations differ from those for human-use products, so importers must identify the intended species of use before determining the correct regulatory route.