2 Final Coronary Guidances Out

FDA has issued a guidance, Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations, to provide recommendations for information to be included in the device labeling as submitted in PMAs or 510(k)s for Class 2 and 3 devices. The document is intended to enhance the consistency of coating-related information across the product areas, as well as to promote safe use of the devices in the clinical setting, the agency says.

A second guidance, Coronary, Peripheral, and Neurovascular Guidewires—Performance Tests and Recommended Labeling, includes recommendations for 510(k) submissions for guidewires intended for use in the coronary vasculature, peripheral vasculature, and neurovasculature. The document says the recommendations reflect current practices and are intended to promote consistency and to facilitate efficient review of the submissions.