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Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use Guidance for Industry and Food and Drug Administration Staff September 2020

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

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.1 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.

1 While the majority of SMBG devices are intended for home use, this also applies to SMBG devices intended for home use that are obtained with a prescription from a healthcare professional.

Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-1446.

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