US FDA Issues Labeling Guidelines For Chemically Coated Devices
Executive Summary
After discovering a correlation between certain chemically coated devices and serious adverse events, the agency has issued a couple of final guidance documents, including a labeling guidance to increase public awareness of the risks. The coating is meant to help physicians more easily slide devices – such as catheters and guidewires – into patients, but in some cases they’ve been associated with obstruction of blood vessels, stroke and death.
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