News | Guidewires | October 11, 2019

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

Pair of guidances address performance testing and labeling considerations for cath lab devices with lubricious coatings as well as guidewires

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

October 11, 2019 — The U.S. Food and Drug Administration (FDA) issued two final guidances for the performance testing and labeling of cardiac catheterization lab devices.  

Intravascular Catheters, Wires and Delivery Systems with Lubricious Coatings - Labeling Considerations addresses labeling considerations for devices containing lubricious coatings used in the vasculature. The guidance is intended 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. 

The FDA said 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 the full guidance here.

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.

Read the article “Recent Advances in Interventional Guidewire Technology“  

The FDA said these recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of these submissions.

Read the full guidance here.

For more information: www.fda.gov

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