Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use: Guidance for Industry and Food and Drug Administration Staff

Issue Date: September 29, 2020
Issued by: Center for Devices and Radiological Health
Topic(s): Premarket, CLIA (Clinical Laboratory Improvement Amendments), IVDs (In Vitro Diagnostic Devices), General Hospital & Personal Use , Clinical Chemistry & Clinical Toxicology
Status: Final

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use: Guidance for Industry and Food and Drug Administration Staff

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-Counter Use ” (SMBG guidance). FDA is also issuing a revised SMBG guidance to reflect similar clarifications to the ones discussed in this guidance.

Download the Guidance Document