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FDA issues two guidance documents on chemically-coated devices

  • Posted by: inetika
  • Category: GLOBAL NEWS

The US Food and Drug Administration (FDA) has published two final guidance documents intended to provide manufacturers with information on  potential risks from certain devices, including catheters and guidewires, that are coated in materials to make introduction easier.

The guidelines are:

Lubricious coatings help guidewires pass through introduction systems, veins and arteries more easily by reducing friction, but experience reports to FDA have shown that if the coating flakes off, it can cause adverse events including heart attack, stroke, tissue necrosis and death.