{"abstract":"The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled \"Providing Information about Pediatric Uses of Medical Devices.\" FDA is issuing this guidance document to describe how to compile and submit the readily available pediatric use information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).","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/2014/05/01/2014-09897.html","cfr_references":[],"citation":"79 FR 24731","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-2009-N-0458"],"dockets":[],"document_number":"2014-09897","effective_on":null,"end_page":24732,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2014/05/01/2014-09897.xml","html_url":"https://www.federalregister.gov/documents/2014/05/01/2014-09897/providing-information-about-pediatric-uses-of-medical-devices-guidance-for-industry-and-food-and","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2014-09897?publication_date=2014-05-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2014-05-01/2014-09897/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":207,"last_updated":"2026-07-28 06:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2014-05-01/pdf/2014-09897.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2014-09897.pdf?1398862197","publication_date":"2014-05-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2014/05/01/2014-09897.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Tab A - \"Draft Regulatory Action, April 1, 2010\" - [OMB Review, Executive Order12866, RPMS Note to the Division of Docket Management, April 19, 2010\" - (Medical Device; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From","document_id":"FDA-2009-N-0458-0004"}],"regulatory_plan":{"html_url":"https://www.federalregister.gov/regulations/0910-AG29/requirement-for-submission-of-information-on-pediatric-subpopulations-that-suffer-from-a-disease-or-","title":"Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended To Treat, Diagnose, or Cure"},"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2009-N-0458","supporting_documents_count":1,"docket_id":"FDA-2009-N-0458","regulation_id_number":"0910-AG29","title":"Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations that Suffer from a Disease or Condition that a Device is Intended to Treat, Diagnose, or Cure-CLOSED","checked_regulationsdotgov_at":"2014-05-21T08:07:18Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":24731,"subtype":null,"title":"Providing Information About Pediatric Uses of Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability","toc_doc":"Pediatric Uses of Medical Devices; Providing Information","toc_subject":"Guidance for Industry and Staff:","topics":[],"type":"Notice","volume":79}