{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled \"Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use\". This draft guidance document describes studies and criteria FDA recommends in premarket submissions for self-monitoring blood glucose test systems (SMBGs) which are for over-the-counter (OTC) use by lay-persons. When finalized, FDA intends for this document to guide manufacturers in conducting appropriate performance studies and preparing premarket notifications for these device types. This draft guidance is not final nor is it in effect at this time.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2014/01/07/2014-00022.html","cfr_references":[],"citation":"79 FR 829","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 7, 2014.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-1446"],"dockets":[],"document_number":"2014-00022","effective_on":null,"end_page":830,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/01/07/2014-00022.xml","html_url":"https://www.federalregister.gov/documents/2014/01/07/2014-00022/self-monitoring-blood-glucose-test-systems-for-over-the-counter-use-draft-guidance-for-industry-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-00022?publication_date=2014-01-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-01-07/2014-00022/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":925,"last_updated":"2026-10-25 04:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-01-07/pdf/2014-00022.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-00022.pdf?1389016395","publication_date":"2014-01-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/01/07/2014-00022.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2014-02-19T05:12:52Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":829,"subtype":null,"title":"Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; Draft Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use","toc_subject":"Draft Guidance for Industry and Staff; Availability:","topics":[],"type":"Notice","volume":79}