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Guidance Issuing OfficeCenter for Devices and Radiological Health
This draft guidance document describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for blood glucose monitoring systems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. When finalized, this guidance document is intended to guide manufacturers in conducting appropriate performance studies and preparing 510(k) submissions for these device types, and will replace 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FDA is also issuing a revised draft of the SMBG guidance to reflect similar clarifications to the ones proposed in this draft guidance.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-1445.