Research Progress and Regulatory Review Focuses of PEG-based Medical Sealants

Polyethylene glycol(PEG)-based medical sealants are a class of medical devices that seal blood vessels or tissue gaps through a curing reaction. They are primarily used in scenarios such as pulmonary air leak management and dural closure. Currently, there is a lack of dedicated guiding principles and standards for these products. This article reviews the application research, domestic and international market approval status, and usage risks of PEG-based medical sealants. It systematically elaborates on the key regulatory review considerations for these products from the perspectives of overview documentation, non-clinical research, clinical evaluation data, and product labeling, aiming to provide a reference for the design, development, and technical review of related products.