{"abstract":"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.","action":"Notice of availability.","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/2016/10/11/2016-24431.html","cfr_references":[],"citation":"81 FR 70120","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.","disposition_notes":null,"docket_ids":["Docket No. FDA-2013-D-1446"],"dockets":[],"document_number":"2016-24431","effective_on":null,"end_page":70122,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2016/10/11/2016-24431.xml","html_url":"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","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2016-24431?publication_date=2016-10-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2016-10-11/2016-24431/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":407,"last_updated":"2026-10-24 02:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2016-10-11/pdf/2016-24431.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2016-24431.pdf?1475844394","publication_date":"2016-10-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2016/10/11/2016-24431.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2013-D-1446","supporting_documents_count":0,"docket_id":"FDA-2013-D-1446","regulation_id_number":null,"title":"Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use","checked_regulationsdotgov_at":"2016-10-31T06:00:24Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":70120,"subtype":null,"title":"Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use; 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":"Guidance:","topics":[],"type":"Notice","volume":81}