FDA has released two final guidance documents featuring recommendations about guidewires and other devices used in vascular procedures.
One document addresses the testing and labeling of coronary, peripheral and neurovascular guidewires. The other text covers the labeling of intravascular catheters, wires and delivery systems with lubricious coatings.
FDA, which issued the documents Wednesday, finalized the texts after reviewing feedback from organizations including AdvaMed and Cook Group.
The guidance on coronary, peripheral and neurovascular guidewires provides recommendations to help device developers file 510(k) submissions. FDA outlines the information companies should include in their filings and describes the content and format of its preferred side-by-side comparison of the device to its predicate.
Notable changes to the 2018 draft guidance on coronary, peripheral and neurovascular guidewires include the addition of a section on potential adverse events. FDA now recommends companies include details of potential device-related adverse events in the instructions for use or package insert. Examples of potential adverse events companies may disclose range from allergic reactions to death.
The other guidance discusses the labeling information developers of vascular devices with lubricious coatings should include in premarket applications and 510(k) submissions. Companies add coatings, such as polyvinylpyrrolidone, to reduce friction and thereby make their devices easier to maneuver. However, there is evidence the coating can separate from the device, creating a health risk.
FDA addresses that risk and its effect on product labeling in the guidance, which underwent several changes on the road to finalization. Many of the larger changes to the guidance relate to a table of items FDA wants companies to consider when developing product labeling.
The agency removed a recommendation that guidewires indicated for peripheral vascular use carry a warning that their safety and effectiveness hasn't been established in the coronary vasculature or neurovasculature. The agency has also deleted a recommendation that devices intended for use in vessels of a particular size include that information on their labels.
The draft texts attracted feedback from a handful of organizations including AdvaMed. Many of the big changes made by FDA were unrelated to the feedback from AdvaMed, which only proposed a fairly short list of minor revisions to the drafts posted for consultation last year.