federal_register: 2016-24431

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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
2016-24431 Self-Monitoring Blood Glucose Test Systems for Over-the-Counter 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 "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use." This document describes studies and criteria that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems (SMBGs) intended for over-the-counter (OTC) home use by lay-users. 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/2016/10/11/2016-24431/self-monitoring-blood-glucose-test-systems-for-over-the-counter-use-guidance-for-industry-and-food https://www.govinfo.gov/content/pkg/FR-2016-10-11/pdf/2016-24431.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 "Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use." This document describes studies and criteria that FDA recommends be used...  

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