FDA creates a device class for room-temperature vascular-graft storage solutions

The Food and Drug Administration has created a new category of regulated device for solutions used to flush and store vascular grafts during surgery, classifying the "flushing and storage solution for vascular autografts at room temperature" into Class II with special controls [s1]. The final order was published in the Federal Register on 30 September 2026 and is effective that day; the underlying classification was applicable from 4 October 2023 [s1].

The device type is now codified at 21 CFR 876.4100, within the agency's rules for gastroenterology-urology devices [s1]. The order grows out of a request by Marizyme, Inc., which on 3 January 2023 asked the FDA to classify its DuraGraft Vascular Conduit Solution through the De Novo pathway; the agency issued the classifying order on 4 October 2023 and is now finalising it in the Code of Federal Regulations [s1].

Why a new class was needed

Under the Federal Food, Drug, and Cosmetic Act, any device that was not in commercial distribution before 28 May 1976 is automatically placed in Class III — the highest-risk tier, which requires premarket approval — regardless of the actual risk it poses, until the FDA takes an action to classify or reclassify it [s1]. The De Novo process, authorised under section 513(f)(2) of the Act, lets the maker of a genuinely novel but low- or moderate-risk device ask the agency to classify it into Class I or II instead. The FDA is required to classify a De Novo device by written order within 120 days [s1].

Classifying a device into Class II is a judgement that general controls alone are not enough to assure safety and effectiveness, but that "special controls" — specific testing and labelling requirements — can close the gap when combined with the general controls [s1]. In reaching that conclusion for the storage solution, the agency determined that such special controls would provide a reasonable assurance of safety and effectiveness, and said the lower classification would also ease patients' access to the technology by lifting the automatic Class III premarket-approval burden [s1].

What the solution does, and the risks the FDA named

The device is used for flushing or short-term storage of vascular grafts, and is intended to maintain the cell viability and structural integrity of those grafts during short-term storage at room temperature during a surgical procedure [s1] — for example, holding a vein harvested for a coronary artery bypass before it is implanted.

The order sets out the risks to health the agency identified and the measures required to mitigate each [s1]. They are adverse tissue reaction, addressed through biocompatibility evaluation; damage to the graft leading to major adverse cardiac events or vascular injury; particulate-matter contamination leading to vascular occlusion, coronary artery embolisation and occlusion, phlebitis, infarction and death; and infection, addressed through sterilisation validation [s1]. For the graft damage and particulate risks, the agency requires clinical performance data, non-clinical performance testing, shelf-life testing and labelling [s1].

The bar for future products

Because this is a De Novo classification, it does more than approve one product. Once the FDA places a device type into Class II, that device can serve as a predicate for future products of the same type, so later manufacturers can use the less burdensome 510(k) premarket-notification route rather than filing a De Novo request or a premarket-approval application [s1]. The special controls written into 21 CFR 876.4100 therefore become the entry test for the whole category.

Those controls are specific. Clinical data must evaluate adverse events from clinical use, and for solutions indicated for coronary artery bypass graft surgery the data must include the incidence of major adverse cardiac events, vein graft occlusion and mortality [s1]. Non-clinical testing must show the device maintains cell viability and structural integrity at the labelled temperature and storage duration, and must evaluate visible and non-visible particulates in the final mixed solution [s1]. The device must also demonstrate shelf-life stability, biocompatibility and sterility, and its labelling must state the maximum storage duration, the additives added at the point of care, the need for visual inspection for particulates, and the stability of the final solution after preparation [s1].

The agency has not exempted the device type from premarket notification under section 510(m), so individual products in the category still require a 510(k) submission before marketing [s1]. In practical terms, the order converts a case-by-case, highest-tier review into a defined moderate-risk pathway with a fixed evidence bar — a routine but consequential piece of device regulation that sets the terms on which competing graft-storage solutions can reach operating rooms.

Sources

• [s1] Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature — Food and Drug Administration / Federal Register, 30 September 2026.