FDA Issues Final Guidances on Guidewires, Intravascular Catheters, and Delivery Systems

Today, the U.S. Food and Drug Administration (FDA) issued two final guidances:  Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations addresses labeling considerations for devices containing lubricious coatings used in the vasculature 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.  These labeling recommendations should be considered for inclusion as current device labeling is updated, and for labeling included as part of future premarket submissions for devices with lubricious coatings.

Read This Guidance Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling provides recommendations for content, performance testing, and labeling to include in a premarket notification (510(k)) submissions for guidewires intended for use in the coronary vasculature, peripheral vasculature, and neurovasculature .   These recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of these submissions. Read This Guidance Questions? If you have questions about these final guidances, contact the Division of Industry and Consumer Education.