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Regulatory science for hernia mesh: Current status and future perspectives
Wenbo Liu1,2, Yajie Xie1, Yudong Zheng1
1School of Material Science and Engineering, University of Science and Technology Beijing, 30 Xueyuan Road, Haidian District, Beijing, China.
Bioactive Materials
|September 30, 2020
Summary
This review examines the regulatory science of hernia mesh implants, comparing Chinese and American markets. It proposes new methods for evaluating medical device safety and effectiveness, advancing regulatory science for implantable devices.
Area of Science:
- Regulatory science
- Biomaterials
- Medical device evaluation
Background:
- Hernia mesh implants are widely used biomaterials.
- Regulatory science ensures medical device safety and effectiveness.
- A comparative analysis of Chinese and American hernia mesh markets is presented.
Purpose of the Study:
- To review the current regulatory science system for hernia mesh.
- To explore future research directions in hernia mesh regulatory science.
- To provide a basis for developing regulatory science for implantable medical devices.
Main Methods:
- Information collection and review of hernia mesh products and biomaterials.
- Analysis of regulations, standards, and guidance documents.
- Assessment of new evaluation tools like computational modeling and big data.
Main Results:
- The current state of hernia mesh regulatory science, including classification and evaluation methods, is reported.
- New preclinical and evaluation tools for hernia mesh safety and effectiveness were assessed.
- The concepts of evidence-based regulatory science and technical review were introduced.
Conclusions:
- Hernia mesh regulatory science serves as a case study for implantable medical devices.
- Systematic evaluation of medical device safety and effectiveness can improve regulatory decision-making.
- This review offers a foundation for advancing regulatory science in the field.
