The U.S. Food and Drug Administration (FDA) has issued a guidance document on what labeling and other information should be included when submitting premarket applications (PMAs) and 510(k) clearance applications for coated implantable medical devices.
The guidance recommends that class III and class II device submissions include more information on the coatings of the devices to promote the safe use of the products in the clinical setting.
"These devices often have hydrophilic and/or hydrophobic lubricious coatings (e.g., polyvinylpyrrolidone (PVP), polytetrafluoroethylene (PTFE), silicone) to reduce friction between devices, and between device(s) and blood vessels," the FDA wrote. "It is commonly believed that these coatings may offer physicians greater maneuverability and may result in less trauma to blood vessels for patients."
The communiqué covers devices such as intravascular catheters, guidewires, balloon angioplasty catheters, delivery sheaths, and implant delivery systems, which are commonly used in minimally invasive procedures in the cerebrovascular, cardiovascular, and peripheral vascular systems.
Interested parties may submit electronic comments and suggestions at any time for the FDA's consideration.