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

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