FDA classifies vascular-autograft flushing and storage solution
Oct 11, 2026 edition · GC-2026-0165 · Published 2026-10-11 · Version 3 · Final
FDA's September 30 order codifies Class II special controls for room-temperature flushing and short-term storage solutions for vascular autografts. The classification dates to October 4, 2023 and remains subject to premarket notification; its performance and labeling controls are specific to the defined device type.
What happened
FDA's final order effective September 30 codifies the vascular-autograft flushing and storage-solution classification in 21 CFR 876.4100. The classification was applicable October 4, 2023, when FDA issued the underlying De Novo order following review of the DuraGraft request. The generic device is used during a surgical procedure to maintain vascular-graft cell viability and structural integrity during short-term storage at room temperature. Class II treatment combines general and special controls; the order expressly states that FDA has not exempted this device type from 510(k) premarket notification.
The special controls require clinical adverse-event data and specified additional outcomes for coronary-bypass uses, nonclinical testing of graft viability and integrity at labeled storage conditions, and evaluation of visible and nonvisible particulates. They also address chemical-component stability over shelf life, biocompatibility, and sterility. Labeling must state maximum storage time, point-of-care additives, visual particulate inspection, final-solution stability, and supporting clinical and nonclinical results. These requirements define the regulated category and its evidence, rather than authorizing every surgical storage solution or dispensing with product-specific regulatory review.
Scope and timing
- Authority status
- Final
- Applicability
- Operationally relevant
- Audience
- Health systems, Health-tech
- Jurisdiction
- Federal
Why it matters
Manufacturers and procurement teams for this device category need to assess the specific classification and special controls, not generalize it to every surgical storage solution.
Recommended action
For affected products, have regulatory affairs reconcile device labeling, performance evidence and procurement specifications with the final order.
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 2026-10-11
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