News | Guidewires | June 14, 2018

FDA Issues Draft Guidance for Guidewires, Catheters, Delivery Systems

Guidance documents provide recommendations on premarket testing and labeling of devices for 510(k) and PMAs

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

June 14, 2018 — The U.S. Food and Drug Administration (FDA) released the following two draft guidance documents:

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The “Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling” draft guidance provides draft recommendations for 510(k) submissions for certain guidewires intended for use in the coronary, peripheral and neurovasculature. This draft guidance includes recommendations for descriptive characteristics, labeling, biocompatibility, sterility, non-clinical testing and animal/clinical performance testing.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The “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations” draft guidance addresses labeling considerations for devices containing lubricious coatings used in the vasculature, some of which are also within the scope of the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 Nov. 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.

The FDA welcomes comments regarding these draft guidance documents.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.

For more information:


Related Guidewire Content

The Basics of Guide Wire Technology

Understanding the Design and Function of Guidewire Technology

VIDEO: Basics of Interventional Guidewire Design and Function, an interview with guidewire expert Dimitri Karmpaliotis, M.D., Ph.D., FACC, professor of medicine, Columbia University Medical Center, and director of CTO, complex and high-risk angioplasty program at the Center for Interventional Vascular Therapy, NewYork-Presbyterian Hospital.

Related Content

Complete Revascularization Superior to Culprit Lesion-only Intervention
News | Cath Lab | September 10, 2019
An international randomized trial has shown that complete revascularization reduces major cardiovascular events...
The cath lab staff UH Portage Medical Center.

The cath lab staff UH Portage Medical Center.

Feature | Cath Lab | September 09, 2019 | Anjan Gupta, M.D., FACC, FSCAI
Primary percutaneous coronary intervention (PCI) is the preferred treatment for acute...
FDA Grants Shockwave Medical Breakthrough Status for Coronary Intravascular Lithotripsy
News | Cath Lab | September 03, 2019
Shockwave Medical Inc. has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA)...
Compound Could Help Improve Heart Attack Recovery
News | Cath Lab | August 27, 2019
Imagine there were a drug that you could take soon after a heart attack that could reduce damage by protecting healthy...
New Alliance Announced Between Transcatheter Cardiovascular Therapeutics and VEITHsymposium
News | Cath Lab | June 20, 2019
VEITHsymposium and the Cardiovascular Research Foundation (CRF) announced an alliance between Transcatheter...
Novel Index Accurately Predicts PCI Success Post-Procedure Compared to Established Measurement Metrics
News | Cath Lab | June 19, 2019
Results from a comprehensive analysis demonstrate the effectiveness of measuring a non-hyperemic pressure ratio (NHPR...
Philips Healthcare, Volcano IVUS showing an implanted stent. IVUS might offer an alternative to contrast angiography in patients with acute kidney disease (AKD).
News | Cath Lab | June 14, 2019
June 14, 2019 – A late-breaking study examined the effects of intravascular ultrasound (IVUS) guided drug-eluting ste
Videos | Cath Lab | May 20, 2019
This is a walk through of the primary structural heart hybrid cath lab at...
Overlay Init