Classification predates this codification
FDA’s September 30, 2026 order adds 21 CFR 876.4100, classifying room-temperature vascular autograft flushing and storage solutions as Class II with special controls. The order took effect that day; FDA says the classification had already applied since October 4, 2023.
In 2023, FDA classified DuraGraft Vascular Conduit Solution through De Novo review. The 2026 order codifies the device type and controls. The category is not exempt from 510(k) notification. A subsequent device still needs an assessment of its intended use and technical evidence to establish substantial equivalence.
The generic definition concerns intraoperative flushing or short-term storage at room temperature to maintain vascular graft cell viability and structural integrity. It is not a classification covering every tissue-preservation medium or storage temperature.
DEN230002 identifies product code QEJ. DuraGraft’s authorized indication concerns adult coronary bypass surgery and flushing and storage of saphenous vein grafts between harvesting and grafting for up to four hours; it is not intended for direct injection or intravenous infusion. Those patient, graft and duration restrictions belong to the specific product, distinct from the generic definition.
Six control categories address different evidence
Clinical data must evaluate adverse events associated with device use. For coronary bypass graft indications, the regulation specifically includes major adverse cardiac events, vein graft occlusion and mortality. Cell or tissue performance evidence does not replace that clinical evaluation.
Non-clinical testing must address maintenance of cell viability and structural integrity at the labeled storage temperature and duration, and visible and non-visible particulates in the final mixed solution. Preservation performance and particulate-related risks are separate questions; a cell-viability endpoint alone does not cover both.
Shelf-life testing must demonstrate chemical-component stability over the identified shelf life. That period differs from the stability of the solution after preparation, which is separately addressed in labeling. An unopened-product shelf-life conclusion alone does not establish post-preparation use duration.
Biocompatibility and sterility are the fourth and fifth controls. The device must be biocompatible and performance data must demonstrate sterility. Section 876.4100 itself does not specify a particular ISO 10993 edition, a fixed sterility-assurance level or an endotoxin limit. Other applicable requirements need separate assessment; numbers in a news lead are not necessarily express requirements in this provision.
Labeling must state maximum storage duration, point-of-care additives or supplements, visual particulate inspection before use, stability duration after preparation, and summaries of supporting non-clinical and clinical data. It communicates both the use boundary and evidence supporting the device.
Distinguish four-hour labeling from the generic requirement
The regulation requires each device to identify its supported maximum duration and demonstrate performance at the labeled temperature and duration. It does not make DuraGraft’s four-hour indication a uniform maximum for every device in the type.
Proposed temperature, duration, preparation and additives define the conditions that evidence and labeling need to address. Copying the original product’s instructions does not replace device-specific support. Different proposed conditions also raise evidence and substantial-equivalence questions.
The original De Novo review identifies a further distinction. FDA found the reviewed clinical studies supportive of safety but no clear clinical evidence of greater effectiveness than standard care. The review also states that the vein-wall-thickness biomarker has not been established as a surrogate for long-term patency. An authorized indication, non-clinical performance and clinical superiority are different conclusions.
The order establishes the generic classification and six special-control categories. The De Novo review explains how one product was authorized within its own indication and evidence boundaries. Both documents are useful for development and registration, but they serve different purposes.
Sources
- Primary official sourceMedical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature (opens in a new tab)U.S. Food and Drug Administration
- Supporting sourceDe Novo Classification Request for DuraGraft Vascular Conduit Solution (DEN230002) (opens in a new tab)U.S. Food and Drug Administration