Final rule · 2026-18431

Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access

The Food and Drug Administration (FDA) is classifying the extravascular support for an arteriovenous fistula for vascular access into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the extravascular support for an arteriovenous fistula for vascular access. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of the safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.