Originally Published MDDI January 2005
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Coated devices that include drugs or biologics are regulated as combination products by more than one of FDA's centers. Those without drugs are regulated exclusively by CDRH. Examples include hydrophilic guidewires and catheters, and orthopedic implants with thermal spray metallic coatings.
Devices with surface chemical modifications are not truly coated, since no layer is physically applied to the device. These devices include surface-hardened orthopedic implants and some plasma-treated devices, including catheters, and are regulated exclusively by CDRH.
Surface modifications can also be used to improve a coating's adhesion to a device. When used as an adhesion promoter, the modified surface is not intended to be the interface with the biological environment. However, there are certain exceptions. If the modified surface extends beyond the coating, or if the coating degrades and exposes the underlying modified surface, the biocompatibility of the modified surface must be acceptable for the device's intended use.
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