Using Regulatory Science Tools to Facilitate the Development of Innovative Medical Devices
This paper explores the definition of regulatory science and how it differs from research science.It introduces regulatory science tools,priorities,and related programs of Food and Drug Administration(FDA)for the development of innovative medical devices.Faced with the challenges of emerging technologies and industry evolution,regulatory agencies need to leverage regulatory science.By utilizing effective regulatory science tools,valuable scientific tools can be transformed into valuable regulatory tools.This approach accelerates the development and marketing authorization of medical devices,ensuring their safety,efficacy,quality,and performance to meet the urgent needs of patients.
regulatory sciencedefinitionregulatory science toolsprioritiesdevelopment of innovative medical devices
国家科技期刊平台
NSTL
万方数据
