FDA Issues Draft Guidances for Recommended Premarket Testing and Labeling for Guidewires, Intravascular Catheters, and Delivery Systems

FDA Issues Draft Guidances for Recommended Premarket Testing and Labeling for Guidewires, Intravascular Catheters, and Delivery Systems 

Today, the U.S. Food and Drug Administration (FDA) released the following two draft guidance documents: 

• Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling
• Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations

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 premarket approval applications (PMAs) or premarket notification (510(k)s).

The “Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling” draft guidance provides draft recommendations for 510(k) submissions for certain guidewires intended for use in the coronary, peripheral, and neurovasculature. This draft guidance includes recommendations for descriptive characteristics, labeling, biocompatibility, sterility, non-clinical testing, and animal/clinical performance testing. When finalized, this guidance will supersede the 1995 Coronary and Cerebrovascular Guidewire Guidance.

The “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations” draft guidance addresses labeling considerations for devices containing lubricious coatings used in the vasculature, some of which are also within the scope of the above-referenced guidewire guidance. The guidance recommendations are based on information received and analyzed by FDA concerning serious adverse events associated with hydrophilic and/or hydrophobic coatings separating (e.g., peeling, flaking, shedding, delaminating, sloughing off) from intravascular medical devices; for more details see FDA Safety Communication for Lubricious Coating Separation from Intravascular Medical Devices issued on November 23, 2015. This guidance document is intended to enhance the consistency of coating-related information in marketing submissions as well as promote the safe use of these devices in the clinical setting.

We welcome your comments regarding these draft guidance documents. The comment period will be open for 60 days in the Federal Register under docket numbers FDA-2018-D-1775 and FDA-2018-D-1788  starting June 15, 2018.

If you have questions regarding these guidance documents, please contact the FDA Division of Industry and Consumer Education (DICE) at the Center for Devices and Radiological Health (CDRH). Contact DICE at (800) 638-2041 or 301-796-7100 between 9:00 a.m. - 12:30 p.m. and 1:00 p.m. - 4:30 p.m. Eastern Time or by email at DICE@fda.hhs.gov.

Food and Drug Administration
Center for Devices and Radiological Health