{"abstract":"Food and Drug Administration (FDA) is announcing the availability of the final guidance entitled, \"Infusion Pumps Total Product Life Cycle; Guidance for Industry and FDA Staff.\" The recommendations in this guidance are intended to improve the safety and effectiveness of these devices. This guidance also describes considerations in preparing premarket submissions for infusion pumps and identifies device features that manufacturers should address throughout the total product life cycle.","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/2014/12/02/2014-28267.html","cfr_references":[],"citation":"79 FR 71434","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-2010-D-0194"],"dockets":[],"document_number":"2014-28267","effective_on":null,"end_page":71435,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/12/02/2014-28267.xml","html_url":"https://www.federalregister.gov/documents/2014/12/02/2014-28267/infusion-pumps-total-product-life-cycle-guidance-for-industry-and-food-and-drug-administration-staff","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-28267?publication_date=2014-12-02","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-12-02/2014-28267/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":923,"last_updated":"2026-07-27 10:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-12-02/pdf/2014-28267.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-28267.pdf?1417468473","publication_date":"2014-12-02","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/12/02/2014-28267.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-2010-D-0194","supporting_documents_count":0,"docket_id":"FDA-2010-D-0194","regulation_id_number":null,"title":"Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: Infusion Pump – Premarket Notification (510(k)) Submissions; Availability","checked_regulationsdotgov_at":"2015-01-12T19:20:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":71434,"subtype":null,"title":"Infusion Pumps Total Product Life Cycle; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Infusion Pumps Total Product Life Cycle","toc_subject":"Guidance:","topics":[],"type":"Notice","volume":79}