{"abstract":"The Food and Drug Administration (FDA) is proposing to amend the regulations on premarket approval of medical devices to include requirements relating to the submission of information on pediatric subpopulations that suffer from the disease or condition that a device is intended to treat, diagnose, or cure. Elsewhere in this issue of the Federal Register, we are publishing a companion direct final rule. This proposed rule will provide a procedural framework to finalize the rule in the event we receive significant adverse comment and withdraw the direct final rule.","action":"Proposed rule.","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/2010/04/01/2010-7192.html","cfr_references":[{"chapter":null,"citation_url":null,"part":814,"title":21}],"citation":"75 FR 16365","comment_url":null,"comments_close_on":"2010-06-15","correction_of":null,"corrections":[],"dates":"Submit electronic or written comments on the proposed rule by June 15, 2010. Submit electronic or written comments on the information collection requirements by June 1, 2010.","disposition_notes":null,"docket_ids":["Docket No. FDA-2009-N-0458"],"dockets":[],"document_number":"2010-7192","effective_on":null,"end_page":16370,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2010/04/01/2010-7192.xml","html_url":"https://www.federalregister.gov/documents/2010/04/01/2010-7192/medical-devices-pediatric-uses-of-devices-requirement-for-submission-of-information-on-pediatric","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2010-7192?publication_date=2010-04-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2010-04-01/2010-7192/mods.xml","not_received_for_publication":null,"page_length":6,"page_views":{"count":250,"last_updated":"2026-09-22 06:15:08 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2010-04-01/pdf/2010-7192.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2010-04-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2010/04/01/2010-7192.txt","regulation_id_number_info":{"0910-AG29":{"issue":"201310","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","xml_url":"http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201310&RIN=0910-AG29&operation=OPERATION_EXPORT_XML","priority_category":"Other Significant"}},"regulation_id_numbers":["0910-AG29"],"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":"2010-04-01T16:04:16Z"},"regulations_dot_gov_url":null,"significant":true,"signing_date":null,"start_page":16365,"subtype":null,"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","toc_doc":"Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease, etc.","toc_subject":"Medical Devices; Pediatric Uses of Devices:","topics":["Administrative practice and procedure","Confidential business information","Medical devices","Medical research","Reporting and recordkeeping requirements"],"type":"Proposed Rule","volume":75}