Discussion of Consideration of Race and Ethnicity Factors in Design and Development of Medical Devices

For medical devices, there might have clinical differences in medical device efficacy and safety among different racial and ethnic subgroups. The acceptability of various data generated during the design and development stage of medical devices between different regions and national regulatory agencies faces huge challenges. This study discusses the considerations of racial and ethnic factors in the design and development of medical devices, with a view to improve the quality and availability of safety and effectiveness data under one framework.