federal_register: 2018-26028

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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
2018-26028 Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; Draft Guidance for Industry and Food and Drug Administration Staff; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance for industry and FDA staff entitled "Self-Monitoring Blood Glucose Test Systems for Over-the- Counter Use." This draft guidance document describes studies and information that FDA recommends be used when submitting premarket notifications (510(k)s) for self-monitoring blood glucose test systems (SMBGs) that 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, and long-term care facilities). This draft guidance is not final nor is it in effect at this time. 2018-11-30 2018 11 https://www.federalregister.gov/documents/2018/11/30/2018-26028/self-monitoring-blood-glucose-test-systems-for-over-the-counter-use-draft-guidance-for-industry-and https://www.govinfo.gov/content/pkg/FR-2018-11-30/pdf/2018-26028.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and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance for industry and FDA staff entitled "Self-Monitoring Blood Glucose Test Systems for Over-the- Counter Use." This draft guidance document describes...  

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