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FDA issues draft guidances for premarket testing, labeling of devices in catheter-based procedures
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The FDA issued draft guidance documents for recommended premarket testing and labeling of guidewires, intravascular catheters and delivery systems.
According to a press release from the FDA, these guidance documents provide industry and FDA staff with recommendations on the least burdensome means of assessing the performance of catheters, guidewires, and delivery systems submitted in applications for approval or clearance.
The “Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling” document provides draft recommendations for 510(k) submissions for certain guidewires intended for use in the coronary, peripheral and neurological vasculature. Included in the draft guidance are recommendations for descriptive characteristics, labeling, biocompatibility, sterility, non-clinical testing, and animal/clinical performance testing.
According to the release, this guidance will supersede the 1995 Coronary and Cerebrovascular Guidewire Guidance when finalized.
The “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations” draft guidance addresses labeling considerations for devices containing lubricious coatings used in the vasculature, some of which are also within the scope of the guidewire draft guidance.
These recommendations are based on analysis by FDA concerning serious adverse events linked to hydrophilic and/or hydrophobic coatings separating from intravascular medical devices.
According to the agency, the document is intended to enhance the consistency of coating-related information in marketing submissions and promote the safe use of these devices in the clinical setting.
Questions regarding the guidance documents should be directed to the FDA Division of Industry and Consumer Education at the Center for Devices and Radiological Health at (800) 638-2041 or (301) 796-7100 or by email at DICE@fda.hhs.gov.