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Medical Devices / Regulatory Affairs

FDA Offers Suggestions for Labeling Vasculature Devices with Lubricious Coatings

June 21, 2018
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The FDA released draft guidance offering recommendations for information to include in labeling for devices with lubricious coating, such as intravascular catheters, guidewires, delivery sheaths and implant delivery systems.

The guidance offers labeling recommendations for both Class II and Class III devices. Although some of its considerations could apply to devices with similar coatings used in other types of interventional procedures, the scope of the guidance focuses on devices used in the neuro, coronary and peripheral vasculature.

For those devices, the FDA recommends that the labeling include a statement identifying whether or not the device is coated. If it is coated, a brief description — such as noting if the coating is hydrophilic or hydrophobic, as well as its purpose and location on the device — is suggested.

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