Federal Register #2026-20075

FDA Classifies Room-Temperature Vascular Autograft Flushing and Storage Solutions

The FDA finalized the device classification and special controls for room-temperature vascular autograft flushing and storage solutions; this is a regulatory action, not a purchase request. - Government agency: Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health. - OEM named: Marizyme, Inc.; its DuraGraft Vascular Conduit Solution was the subject of the De Novo classification request. - Device type: A solution used to flush or temporarily store vascular grafts during surgery, intended to maintain cell viability and structural integrity. - Requirements: Class II classification with special controls covering clinical and nonclinical performance data, shelf-life testing, biocompatibility, sterility, and labeling. The device type is subject to 510(k) premarket notification. - No purchase quantity, part number, or requested services are specified.

Description

The FDA classifies flushing and storage solutions for vascular autografts at room temperature as class II medical devices subject to special controls. These devices are used to flush or temporarily store vascular grafts during surgical procedures, with the intent of maintaining cell viability and structural integrity. The special controls include clinical and non-clinical performance data, shelf-life testing, biocompatibility, sterility, and labeling requirements. The final order codifies the classification in 21 CFR 876.4100; the classification was applicable beginning October 4, 2023, and the order is effective September 30, 2026.

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