Introduction and Reflection on Novel Medical Device Regulatory Science Tool MDDT.
10.3969/j.issn.1671-7104.2023.06.016
- Author:
Yingying TENG
1
;
Hengsong SHENG
1
;
Yinghui LIU
1
Author Information
1. Center for Medical Device Evaluation, NMPA, Beijing, 100081.
- Publication Type:Journal Article
- Keywords:
medical device development tool;
medical device evaluation methods;
regulatory science
- MeSH:
United States;
Medical Device Legislation;
Reproducibility of Results;
United States Food and Drug Administration;
Technology;
Device Approval
- From:
Chinese Journal of Medical Instrumentation
2023;47(6):674-679
- CountryChina
- Language:Chinese
-
Abstract:
In recent years, emerging technology medical devices have developed rapidly. How to more scientifically and more efficiently regulate these novel medical devices so as to improve access to advanced medical technology while ensuring safety and effectiveness is a new challenge faced by regulatory authorities, and is also the core topic of regulatory science. New tools, new standards and new methods are important means to achieve regulatory science. "Medical Device Development Tool" proposed by the U.S. FDA is a novel medical device regulatory science tool, which can help medical device developers to predict and evaluate product performance more efficiently. It is also helpful for regulatory authorities to make regulatory decisions more efficiently. This study introduces the concept, qualification process, role of MDDT in medical device regulation and MDDT examples, and makes some discussion on the device evaluation from the perspective of reliability and validity. MDDT can facilitate the developing of novel medical device.
