{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"Safety Considerations to Mitigate the Risks of Misconnections with Small-Bore Connectors Intended for Enteral Applications.\" The use of common connector designs, such as Luer connectors, has led to unintended connections between devices that have different intended uses and has resulted in serious and sometimes fatal consequences to patients. This guidance provides recommendations to manufacturers regarding the expectations for design and testing of small-bore connectors intended for enteral applications (\"enteral devices\"). FDA is making these recommendations to reduce the risk of unintended connections between enteral and non- enteral devices.","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/2015/02/11/2015-02802.html","cfr_references":[],"citation":"80 FR 7612","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-2012-D-0630"],"dockets":[],"document_number":"2015-02802","effective_on":null,"end_page":7614,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2015/02/11/2015-02802.xml","html_url":"https://www.federalregister.gov/documents/2015/02/11/2015-02802/safety-considerations-to-mitigate-the-risks-of-misconnections-with-small-bore-connectors-intended","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2015-02802?publication_date=2015-02-11","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2015-02-11/2015-02802/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":322,"last_updated":"2026-09-22 18:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2015-02-11/pdf/2015-02802.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2015-02802.pdf?1423576469","publication_date":"2015-02-11","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2015/02/11/2015-02802.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-2012-D-0630","supporting_documents_count":0,"docket_id":"FDA-2012-D-0630","regulation_id_number":null,"title":"Draft Guidance for Industry and Food and Drug Administration Staff Safety Considerations for 510k Submissions to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications Availability","checked_regulationsdotgov_at":"2015-03-03T06:00:17Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":7612,"subtype":null,"title":"Safety Considerations To Mitigate the Risks of Misconnections With Small-Bore Connectors Intended for Enteral Applications; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Safety Considerations to Mitigate the Risks of Misconnections with Small-Bore Connectors Intended for Enteral Applications","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":80}