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FDA Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway

蒋千琴 1/18/2022 浏览 282 FDA US

标准简介

Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于US。

标准截图

Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway[附网盘链接]
Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway[附网盘链接](截图)

 

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标准文档类型为Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway[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

Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway ______________________________________________________________________________ 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 This guidance provides performance criteria for cutaneous electrodes in support of the Safety 1

and Performance Based Pathway. Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for cutaneous electrodes for recording purposes will have the option to use the performance criteria proposed in this guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device. For the current edition of the FDA-recognized standard(s) referenced in this document, see the 2

FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical 3

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 1

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-and-performance-

based-pathway 2

Available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 3

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/appropriate-use-

voluntary-consensus-standards-premarket-submissions-medical-devices 3

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