U.S. FEDRegulation
FDA classifies vascular autograft flushing and storage solutions as class II devices
The FDA published a final order on September 30, 2026 (91 FR 61703), effective that day, adding 21 CFR 876.4100 to classify flushing and storage solutions for vascular autografts at room temperature in class II with special controls. Makers must file a 510(k) and meet controls on clinical adverse-event data, performance, shelf life, biocompatibility, sterility and labeling. The classification has applied since October 4, 2023, after Marizyme's De Novo request for its DuraGraft solution.
Key points
- New 21 CFR 876.4100 places flushing and storage solutions for vascular autografts at room temperature in class II with special controls.Federal Register
- Clinical data must cover adverse events; for bypass grafts, major adverse cardiac events, vein graft occlusion and mortality.Federal Register
- Other special controls cover non-clinical performance, shelf life, biocompatibility, sterility and labeling.Federal Register
- The device type remains subject to 510(k) premarket notification.Federal Register
- Effective September 30, 2026 (91 FR 61703); the classification has applied since October 4, 2023.Federal Register
Sources1 article across 1 outlet
Filed under
RegulationU.S.Flushing and Storage Solution for Vascular Autografts ClassificationHealthcareRegulatoryFor practitionersFor governance