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FDA Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices

蒋千琴 10/21/2021 浏览 273 FDA United States

标准简介

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices[附网盘链接]是于当前发布的FDA标准，适用于United States。

标准截图

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices[附网盘链接]
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices[附网盘链接](截图)

 

标准文档说明

标准文档类型为Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices[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

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices 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 Food and Drug Administration (FDA) developed this document to provide guidance to industry and FDA staff about the appropriate use of national and international voluntary consensus standards (referred to as consensus standards) in the preparation and evaluation of premarket submissions for medical devices. For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database Web site at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. 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 guidance means that something is suggested or recommended, but not required. II. Background Voluntary consensus standards can be a valuable resource for industry and FDA staff. The use of consensus standards can increase predictability, streamline premarket review, provide clearer regulatory expectations, and facilitate market entry for safe and effective medical products. Consensus standards provide a consensus approach to certain aspects of the evaluation of device safety and effectiveness, such as testing methods, acceptance criteria, and processes to address areas such as risk management and usability. The use of consensus standards can also promote international harmonization. For decades, FDA has supported and relied on the development and 1

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