federal_register: 2016-24430

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2016-24430 Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use; Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use." This 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 in professional healthcare settings. FDA intends for this document to serve as a guide for manufacturers in conducting appropriate performance studies and preparing 510(k)s for these device types. 2016-10-11 2016 10 https://www.federalregister.gov/documents/2016/10/11/2016-24430/blood-glucose-monitoring-test-systems-for-prescription-point-of-care-use-guidance-for-industry-and https://www.govinfo.gov/content/pkg/FR-2016-10-11/pdf/2016-24430.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled "Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use." This document describes studies and criteria that FDA recommends be...  

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