FDA Adaptive Designs for Medical Device Clinical Studies
标准简介
Adaptive Designs for Medical Device Clinical Studies[附网盘链接]是FDA于不久前发布的FDA标准，适用于U.S。标准截图
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标准文档说明
标准文档类型为Adaptive Designs for Medical Device Clinical Studies[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Adaptive Designs for 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. 1. Introduction and Scope An adaptive design for a medical device clinical study is defined as a clinical study design that allows for prospectively planned modifications based on accumulating study data without undermining the study’s integrity and validity. Adaptive designs, when properly implemented, can reduce resource requirements, decrease time to study completion, and/or increase the chance of study success. This guidance provides sponsors and Food and Drug Administration (FDA) staff with guidance on how to plan and implement adaptive designs for clinical studies when used in medical device development programs. This document addresses adaptive designs for medical device clinical studies and is applicable to premarket medical device submissions including Premarket Approval Applications (PMA), premarket notification (510(k)) submissions, de novo submissions (Evaluation of Automatic Class III Designation), Humanitarian Device Exemption (HDE) applications and Investigational Device Exemption (IDE) submissions. This guidance can be applied throughout the clinical development program of a medical device, from feasibility 1
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