Regulatory science for hernia mesh: Current status and future perspectives.

摘要: Abstract Regulatory science for medical devices aims to develop new tools, standards and approaches assess the safety, effectiveness, quality performance of devices. In field biomaterials, hernia mesh is a class implants that have been successfully translated clinical applications. With focus on its regulatory system, this paper collected reviewed information products biomaterials in both Chinese American markets. The current development mesh, including regulations, standards, guidance documents classification, scientific evaluation safety effectiveness was first reported. Then research prospect discussed. New methods preclinical animal study tools such as computational modeling, big data platform evidence-based research, were assessed. By taking case study, review provided basis developing system implantable devices, furthering systematic better decision-making. This article reviewing biomaterial-based implants. It also proposed explained concepts technical time.