Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature
Key claim: FDA is placing flushing and storage solutions for vascular autografts used at room temperature into class II, so manufacturers can bring them to market under special controls instead of the stricter premarket approval process.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the flushing and storage solution for vascular autografts at room temperature 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 flushing and storage solution for vascular autografts at room temperature. 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 designation with special controls lets manufacturers of these vascular autograft preservation solutions use the 510(k) pathway rather than the more burdensome premarket approval process, which can accelerate availability of room-temperature storage products used in vascular surgery. The action is narrow and procedural but fits a broader pattern of FDA down-classifying novel device types once risks are better understood.