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FDA Evaluation of Sex-Specific Data in Medical Device Clinical Studies -

蒋千琴 4/10/2022 浏览 367 FDA 美国

标准简介

Evaluation of Sex-Specific Data in Medical Device Clinical Studies -[附网盘链接]是FDA发布的FDA标准，适用于美国。

标准截图

Evaluation of Sex-Specific Data in Medical Device Clinical Studies -[附网盘链接]
Evaluation of Sex-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 of Sex-Specific Data in Medical Device Clinical Studies Guidance for Industry and Food and Drug Administration Staff This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. Introduction This document provides guidance on the study and evaluation of sex-specific data in medical device clinical studies. The purpose of this guidance is to outline the FDA’s expectations regarding sex-specific patient enrollment, data analysis, and reporting of study information. The primary intent is to improve the quality and consistency of available data regarding the performance of medical devices in both sexes by encouraging appropriate enrollment by sex in clinical studies of devices, and that data from such studies is appropriately analyzed by sex. This information can be of benefit to patients and their medical providers, as well as clinical researchers and others. The specific objectives of this guidance are to: 1) encourage the consideration of sex and associated covariates (e.g., body size, plaque morphology, etc.) during the study design stage; 2) provide recommendations for study design and conduct to encourage appropriate enrollment of each sex (e.g., in proportions generally representative of the demographics of disease distribution, if appropriate); 3) outline recommended sex-

specific statistical analyses of study data with a framework for considering sex-specific data when interpreting overall study outcomes; and 4) specify FDA’s expectations for reporting sex-specific information in summaries and labeling for approved or cleared medical devices. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

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