Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access
Key claim: The FDA has classified extravascular supports used to help dialysis fistulas as moderate-risk (class II) devices with special controls, so similar products can follow a lighter review path instead of the strictest approval process.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) 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.
Why this matters
Class II classification with special controls lets future extravascular fistula support devices reach market through the 510(k) pathway rather than the more burdensome premarket approval process, which can affect how quickly dialysis patients get access to new vascular access technologies. The action continues FDA’s pattern of down-classifying novel cardiovascular devices once initial safety and effectiveness data support general controls plus device-specific standards.