The United States (US) Food and Drug Administration (FDA) have issued two final guidances regarding performance tests and labelling considerations for intravascular guidewires, catheters and delivery systems.
The first guidance on guidewires has been created to assist sponsors in preparing performance testing to support 510(k) submissions and also provides recommendations for content and labelling of guidewires intended for use in the coronary, peripheral and neuro-vasculature. It displaces a corresponding guidance from 1995, providing updated information and additional clarity for new or modified guidewires, due to the technological advancements made since then.
The guidance outlines inclusion criteria for premarket submissions such as device description, predicate comparison, biocompatibility, sterility, pyrogenicity, shelf-life and packaging, non-clinical bench testing and clinical performance testing.
As the guidance explains, guidewires are devices for clinical use, so they are exempt from needing adequate labelling directions for lay persons, as long they include adequate information for the intended user of the device such as device description, indications, contraindications, warnings, potential adverse events and directions. The guidance also provides examples of modifications that would and would not require a new 510(k).
The second guidance stipulates labelling considerations for intravascular catheters, wires and delivery systems containing lubricious coatings. These devices are used during minimally invasive diagnostic and therapeutic procedures in vascular systems. They often have lubricious coatings to reduce friction, offering clinicians greater ease of use and less trauma to patients’ vasculature. However, the FDA found recent evidence that the coating may separate in some circumstances. The FDA have reviewed serious adverse events (SAE’s) which have led to multiple recalls of devices with these coatings.
This guidance is specifically directed at class II devices under 23 product codes and class III devices under 16 product codes. The recommended labelling considerations include addition of a statement to identify the device is coated and a description of the coating. It should also include warnings and precautions regarding potential adverse events in the case of coating separation.
The aim of this guidance is to “enhance the consistency of coating-related information across these product areas, as well as to promote the safe use of these devices in the clinical setting”.