FDA classifies vascular-autograft flushing and storage solution

What happened

FDA’s September 30 final order adds 21 CFR 876.4100 for flushing and storage solution used to maintain vascular-graft cell viability and structural integrity during short-term room-temperature storage in surgery. The order is effective September 30, 2026, while the underlying De Novo classification was applicable October 4, 2023. FDA explains that it is now codifying that class II classification, following review of the DuraGraft request, because special controls together with general controls can provide reasonable assurance of safety and effectiveness.

The controls require clinical adverse-event data, nonclinical evidence of graft preservation and particulate performance, shelf-life stability, biocompatibility and sterility. Coronary bypass indications require evaluation of the specified cardiac events, graft occlusion and mortality. Labeling must state maximum storage duration, additives, inspection for particulates, final-solution stability and summaries of supporting evidence. FDA did not exempt the category from 510(k) notification. These requirements apply to the defined vascular-autograft solution type, rather than every surgical storage fluid, and class II status is not a blanket release from premarket requirements.

Why it matters

Manufacturers need evidence and labeling matched to the intended use, while procurement should verify that a product’s authorization covers the actual surgical application. The earlier classification date also prevents the 2026 codification from being misdescribed as a wholly new September category decision.

Sources

• Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room TemperatureOfficial · Health and Human Services Department, Food and Drug Administration · 2026-09-30 · Source review 2026-10-05