federal_register: 2020-21462

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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
2020-21462 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, we, or Agency) is announcing the availability of the final guidance entitled "Self- Monitoring Blood Glucose Test Systems for Over-the-Counter Use." This guidance described 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. This guidance is not meant to address blood glucose monitoring test systems (BGMS) that are intended for prescription point-of-care use in professional healthcare settings (e.g., hospitals, physician offices, long-term care facilities). 2020-09-29 2020 9 https://www.federalregister.gov/documents/2020/09/29/2020-21462/self-monitoring-blood-glucose-test-systems-for-over-the-counter-use-guidance-for-industry-and-food https://www.govinfo.gov/content/pkg/FR-2020-09-29/pdf/2020-21462.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of the final guidance entitled "Self- Monitoring Blood Glucose Test Systems for Over-the-Counter Use." This guidance described studies and information that FDA...  

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