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Guidance Issuing OfficeCenter 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.
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:
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.