Self-monitoring blood glucose test systems for over-the-counter use: guidance for industry and Food and Drug Administration staff

Self-monitoring blood glucose test systems for over-the-counter use: guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, September 29, 2020
Language(s):
English
Format:
Text
Subject(s):
Blood Glucose Self-Monitoring
Device Approval
Equipment Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
This guidance document describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems (SMBGs) which are for over-the-counter (OTC) home use by lay-users. 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 “Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use” issued on October 11, 2016. This guidance is not meant to address blood glucose monitoring test systems which are intended for prescription point-of-care use in professional healthcare settings (e.g., hospitals, physician offices, long term care facilities). FDA addresses those device types in another guidance entitled, “Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use” (BGMS guidance). FDA is also issuing another BGMS guidance to reflect similar clarifications to the ones described in this guidance. For the current edition of the FDA-recognized standard(s) referenced in this document, see the 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 “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (38 pages)).
NLM Unique ID:
9918232102906676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918232102906676