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FDA Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use

蒋千琴 11/11/2021 浏览 210 FDA U.S

标准简介

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use[附网盘链接]由FDA于之前发布，适用于U.S。

标准截图

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use[附网盘链接]
Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use[附网盘链接](截图)

 

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标准部分原文

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use 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 document describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems (BGMSs) which are for prescription point-of-care use. This guidance document is intended to guide manufacturers in conducting appropriate performance studies and preparing 510(k) submissions for these device types, and replaces the final guidance entitled “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use” issued on October 11, 2016. This guidance is not meant to address self-monitoring blood glucose test systems (SMBGs) for over-the-counter (OTC) home use by lay-users. FDA addresses those device types in another guidance entitled “Self-Monitoring Blood Glucose Test Systems for Over-the-

1

Counter Use” (SMBG guidance). FDA is also issuing a revised SMBG guidance to reflect similar clarifications to the ones discussed in this guidance. For the current edition of FDA-recognized standards referenced in this document, see the 2

FDA Recognized Consensus Standards Database Web site. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled 1

Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/self-monitoring-

blood-glucose-test-systems-over-counter-use. 2

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

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