FDA classifies flushing and storage solution for vascular autografts at room temperature as class II
The FDA announced that it is classifying the flushing and storage solution for vascular autografts at room temperature into class II (special controls). The order identifies the special controls that apply to the device type and will be part of the codified language for classification of the flushing and storage solution for vascular autografts at room temperature.
Primary source
Federal Register rule, September 30, 2026
Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature
Read the source: Medical Devices; Gastroenterology-Urology Devices; Classification of the Flushing and Storage Solution for Vascular Autografts at Room Temperature federalregister.gov
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