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FDA Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies

蒋千琴 4/8/2022 浏览 247 FDA 美国

标准简介

Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies[附网盘链接]由FDA于之前发布，适用于美国。

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Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies[附网盘链接]
Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies[附网盘链接](截图)

 

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标准部分原文

Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page. I. Introduction The purpose of this guidance is to outline the FDA’s expectations and provide recommendations for the evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies. The primary intent of these recommendations is to improve the quality, consistency, and transparency of data regarding the performance of medical devices within specific age, racial, and ethnic groups. Proper evaluation and reporting of this data can benefit patients, clinicians, researchers, regulators, and others. Additionally, it is important that clinical trials include diverse populations that reflect the intended use population. In general, to achieve an unbiased estimate of treatment effect in the general population, sponsors should develop a strategy to enroll diverse populations including representative proportions of relevant age, racial, and ethnic subgroups, which are consistent with the intended use population of the device. This guidance includes recommendations and considerations to assist sponsors in developing such a strategy. FDA recognizes the practical challenges in achieving the appropriate enrollment of diverse populations. This guidance includes recommendations to overcome barriers to enrollment in order to balance these recommendations with least burdensome principles. This guidance extends the policy set forth in the FDA’s Evaluation of Sex-Specific Data in 1

Medical Device Clinical Studies Guidance to additional demographic subgroups of age, race, and ethnicity. This guidance also extends and complements FDA’s Collection of Race and 1

See FDA’s guidance Evaluation of Sex-Specific Data in Medical Device Clinical Studies http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm283707.pdf. 5

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