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Guidance Issuing OfficeCenter for Devices and Radiological Health
This draft guidance document addresses labeling considerations for devices containing lubricious coatings used in the vasculature. The purpose of this guidance document is to provide recommendations for information to be included in the device labeling, as submitted in premarket applications (PMAs) or premarket notification submissions (510(k)s) for Class III and Class II devices, to enhance the consistency of coating-related information across these product areas, as well as to promote the safe use of these devices in the clinical setting. Medical devices such as intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems are commonly used during minimally invasive diagnostic and therapeutic procedures in the cerebrovascular, cardiovascular, and peripheral vascular systems. These devices often have hydrophilic and/or hydrophobic lubricious coatings (e.g., polyvinylpyrrolidone (PVP), polytetrafluoroethylene (PTFE), silicone) to reduce friction between devices, and between device(s) and blood vessels. It is commonly believed that these coatings may offer physicians greater maneuverability and may result in less trauma to blood vessels for patients.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-1788.