Historically, FDA has not recommended different types of information in 510(k)s for BGMSs used by healthcare professionals as compared to SMBGs intended for home use by lay-users. In order to distinguish between FDA recommendations for prescription-use blood glucose meters, which are intended for use in point-of-care professional healthcare settings, and SMBG devices intended for home use for self-monitoring by lay-persons, the Agency is issuing two separate guidance’s for
- BGMSs intended for use in point-of-care professional healthcare settings
- SMBGs intended for home use for self-monitoring by lay-users
This guidance document is limited to BGMSs which are regulated under 21 CFR 862.1345.This document describes studies and criteria that FDA recommends be used when submitting 510(k)s for BGMSs which are for prescription point-of-care use in professional settings. FDA believes that in making this distinction, BGMSs can be better designed to meet the needs of their intended use populations, thereby providing greater safety and efficacy. FDA has proposed several studies in this guidance that can be performed in a way that will allow sponsors to request both FDA review of their 510(k) submission clearance and CLIA waiver for their BGMSs concurrently.
This document describes studies that can be conducted to demonstrate BGMS performance for devices intended to be used in diverse professional healthcare settings on subjects in various states of health.
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