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GUIDANCE DOCUMENT

Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use Guidance for Industry and Food and Drug Administration Staff October 2016

Final
Docket Number:
FDA-2013-D-1445
Issued by:
Guidance Issuing Office
Office of In Vitro Diagnostics and Radiological Health

This guidance document describes studies and criteria 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. FDA intends for this document to guide manufacturers in conducting appropriate performance studies and preparing 510(k) submissions for these device types.


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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-1445.