FDA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions
标准简介
Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions[附网盘链接]是FDA于不久前发布的FDA标准，适用于United States。标准截图
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标准文档类型为Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions[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
Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions 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 On February 21, 2018, FDA amended its regulations on the acceptance of data from clinical 1
investigations for medical devices. Under the new rule, FDA is requiring that data submitted from clinical investigations conducted outside of the United States (OUS) intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a humanitarian device exemption (HDE) application, or a product development protocol (PDP) application, be from investigations conducted in accordance with good clinical practice (GCP), which includes review and approval by an independent ethics committee (IEC) and informed 2
consent from subjects. The GCP requirements in the final rule encompass both data quality and integrity and ethical standards for device clinical investigations. The final rule, effective one year after publication, is codified at 21 CFR parts 807, 812, and 3
814. It is intended to help ensure the quality and integrity of clinical data and the protection of human subjects. In particular, we have updated the requirements in 21 CFR part 814 for acceptance of data from clinical investigations conducted OUS, and we have amended 21 CFR parts 807 and 812 to identify criteria for acceptance of data from clinical investigations conducted OUS as well as investigations conducted within the United States (US), which are based on the requirements in 21 CFR part 814. Thus, the final rule provides consistency in 1
“Human Subject Protection; Acceptance of Data from Clinical Investigations for Medical Devices” 83 FR 7366. 2
21 CFR 812.28(a)(1). 3
83 FR 7366.
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