Originally Published MDDI January
2005
Coatings
Surface-Modified Devices and CDRH
Phil Triolo
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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.
Copyright ©2005 Medical Device & Diagnostic Industry
