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FDA Issues Draft Guidance for Guidewires, Catheters, Delivery Systems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June 14, 2018 — The U.S. Food and Drug Administration (FDA) released the following two draft guidance documents: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The “Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling” draft guidance provides draft recommendations for 510(k) submissions for certain guidewires intended for use in the coronary, peripheral and neurovasculature. This draft guidance includes recommendations for descriptive characteristics, labeling, biocompatibility, sterility, non-clinical testing and animal/clinical performance testing.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The “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations” draft guidance addresses labeling considerations for devices containing lubricious coatings used in the vasculature, some of which are also within the scope of the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The FDA welcomes comments regarding these draft guidance documents.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: www.fda.gov

 

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

Videos | Cath Lab | July 15, 2020
Richard Botto, CVT, RCSA, chief cardiovascular technologist, division of cardiology, cardiac cath lab, offers an over
Videos | Cath Lab | July 13, 2020
The Vieussens’ arterial ring (VAR) is a connection between the conus artery and the left anterior descending (LAD) co
News | Cath Lab | July 06, 2020
July 6, 2020 — Black patients who undergo percutaneous coronary intervention (PCI) are at an increased risk for major
TCT cancels in-person meeting and goes virtual due to COVID-19
News | Cath Lab | May 27, 2020
May 27, 2020 — To ensure the health and safety of all attendees due to the ongoing COVID-19 (SARS-CoV-2) pandemic, th
Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, or nil per os (NPO), as there are no current standardized fasting protocols, but the CHOWNOW study found patients do not need to fast and will have similar outcomes. #SCAI2020
Feature | Cath Lab | May 18, 2020
May 18, 2020 – Patients undergoing cardiac catheterization are traditionally instructed to follow nothing by mouth, o
Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiography and Interventions (SCAI) and chief, Division of Cardiovascular Medicine at UC San Diego Medical Center,
Podcast | Cath Lab | May 13, 2020
This podcast is an interview with Ehtisham Mahmud, M.D., FSCAI, president of the Society for Cardiovascular Angiograp
Nuance Communications Inc. introduced Nuance Cardiovascular CAPD, a new computer-assisted physician documentation (CAPD) solution designed to help cardiologists improve the quality of complex documentation and the accuracy of reimbursement for cardiac catheterization procedures. The Nuance Cardiovascular CAPD solution is available through a partnership with ZHealth for this solution, which is based on patented algorithms built with ZHealth’s interventional documentation and coding expertise.
News | Cath Lab | January 31, 2020
January 29, 2020 – Nuance Communications Inc.