FDA Classifies Extravascular Support for Arteriovenous Fistula for Vascular Access into Class II

The U.S. Food and Drug Administration (FDA) has classified the extravascular support for an arteriovenous fistula for vascular access into Class II (special controls). This regulatory action aims to provide reasonable assurance of the device's safety and effectiveness, while also enhancing patient access to beneficial innovative devices by reducing regulatory burdens. The order is effective September 10, 2026.