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# Draft Lubricious Coating Wire Guidance
- URL: https://www.fdaweb.com/draft-lubricious-coating-wire-guidance/
- Published: 2018-06-14T12:00:00.000Z
- Updated: 2026-09-15T00:13:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5141683

FDA has issued a draft guidance, *Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations*, with recommendations for information to be included in the device labeling submitted in PMAs or 510(k)s for Class 3 and 2 devices containing lubricious coatings used in the vasculature to enhance the consistency of coating-related information across the product areas. The [document](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM610630.pdf?ref=fdaweb.com) says the intent also is to promote the safe use of these devices in the clinical setting.