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FDA Issues Draft Guidance for Guidewires, Catheters, Delivery Systems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June 14, 2018 — The U.S. Food and Drug Administration (FDA) released the following two draft guidance documents: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The “Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling” draft guidance provides draft recommendations for 510(k) submissions for certain guidewires intended for use in the coronary, peripheral and neurovasculature. This draft guidance includes recommendations for descriptive characteristics, labeling, biocompatibility, sterility, non-clinical testing and animal/clinical performance testing.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The “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations” draft guidance addresses labeling considerations for devices containing lubricious coatings used in the vasculature, some of which are also within the scope of the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The FDA welcomes comments regarding these draft guidance documents.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

News | Cath Lab

December 20, 2023 — Jason R. McCarthy, Ph.D., associate professor of biomedical research and translational medicine and ...

Home December 20, 2023
Home
News | Cath Lab

October 26, 2023 — Royal Philips, a global leader in health technology, announced the latest results demonstrating the ...

Home October 26, 2023
Home
News | Cath Lab

October 25, 2023 — Shockwave Medical, Inc., a pioneer in the development and commercialization of transformational ...

Home October 25, 2023
Home
News | Cath Lab

October 20, 2023 — Over the coming days, Philips will be presenting its latest solutions in cardiology and new late ...

Home October 20, 2023
Home
News | Cath Lab

October 16, 2023 — GE HealthCare (Nasdaq: GEHC) announced US FDA 510(k) clearance of Allia IGS Pulse - the latest ...

Home October 16, 2023
Home
News | Cath Lab

October 16, 2023 — Shimadzu Medical Systems USA, a subsidiary of Shimadzu Corporation, announced the first U.S ...

Home October 16, 2023
Home
News | Cath Lab

September 13, 2023 — A diagnostic test, first offered in the United States at University Hospitals (UH) Harrington Heart ...

Home September 13, 2023
Home
News | Cath Lab

August 2, 2023 — Teleflex Incorporated, a leading global provider of medical technologies, announced the U.S Food and ...

Home August 02, 2023
Home
News | Cath Lab

July 13, 2023 — Mount Sinai Queens announced the opening of a new cardiac catheterization lab that will provide rapid ...

Home July 13, 2023
Home
News | Cath Lab

June 21, 2023 — Royal Philips, a global leader in health technology, announced it has teamed up with BIOTRONIK (Lake ...

Home June 21, 2023
Home
Subscribe Now