In two draft guidances issued Thursday, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is providing new labeling recommendations for certain devices with guidewires or lubricious coatings.
CDRH intends to ensure consistency among device sponsors when preparing premarket applications or 510(k) submissions across the different product areas with the drafted recommendations.
The 12-page draft guidance on intravascular catheters, wires and delivery systems with hydrophilic and/or hydrophobic coatings is aimed at mitigating serious adverse events. FDA developed the guidance after conducting an analysis of evidence gathered from voluntary recalls and medical device reports. The analysis led to the conclusion that appropriate labeling recommendations can minimize the risks related to clinical use.
From intra-aortic balloons to coronary stents and mitral valve repair devices, the draft guidance’s scope covers a wide range of vascular product areas. Some of the considerations included may be applied to other interventional devices with similar coatings, according to CDRH.
The recommendations include specifics relating to warnings, precautions and preparation steps, among other aspects of labeling designs. Device sponsors are encouraged to consider these to potentially supplement existing designs, rather than replacing any previously included information.
A separate 20-page draft on new or modified guidewires intended for use in coronary, peripheral and neurovascular procedures, when finalized, will replace a 4-page final guidance
issued in 1995 in light of the “many technological advancements” that have emerged since then.
Labeling considerations were not addressed in the previous guidance, though 510(k) submissions are required to include detailed information on the proposed labels and labeling.
“For instance, labeling must include adequate information for the intended use of the device, including indications, effects, routes, methods, frequency and duration of administration and any relevant hazards, contraindications, side effects and precautions,” the draft guidance states.
In addition to the labeling recommendations, this draft guidance also provides further clarifications on performance testing considerations for 510(k) submissions. In contrast with the previous guidance, CDRH indicates that real-world data can be used in some situations as evidence to support expanding indications for these devices.
The new guidance also adds considerations for device description, predicate comparisons as well as shelf life and packaging.
Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations
Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling