United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2010_register executive 2010-04-01 article Proposed Rules D09002ee1c802425d D09002ee1c80242f3 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 75 FR 16365 https://www.govinfo.gov/app/details/FR-2010-04-01/2010-7192 2010-7192 FR01AP10-23 RIN 0910-AG29 4160-01-S Docket No. FDA-2009-N-0458 https://www.govinfo.gov/app/details/FR-2010-04-01/2010-7192 https://www.govinfo.gov/content/pkg/FR-2010-04-01/html/2010-7192.htm https://www.govinfo.gov/content/pkg/FR-2010-04-01/pdf/2010-7192.pdf Administrative Practice and Procedure Confidential Business Information Medical Devices Medical Research Reporting and Recordkeeping Requirements 6 p. 16365 16370 75 FR 16365 Title 21 Part 814 21 CFR Part 814 RIN 0910-AG29 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; Federal Register Vol. 75, Issue PRORULE 2010-7192 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2010-06-15 Docket No. FDA-2009-N-0458 4160-01-S 2010-7192 Proposed rule.

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.

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. Robert Gatling, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1640, Silver Spring, MD 20993, 301-796- 6560. Administrative Practice and Procedure Confidential Business Information Medical Devices Medical Research Reporting and Recordkeeping Requirements Medical Devices; Pediatric Uses of Devices: Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease, etc. , http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089402.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089733.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089764.htm http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm http://www.regulations.gov Vol. 75, no. 62 Office of the Federal Register, National Archives and Records Administration 2010-04-01 continuing daily deposited born digital 323 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2010-04-01 P0b002ee1801d7b45 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:FR01AP10 https://www.govinfo.gov/app/details/FR-2010-04-01 https://www.govinfo.gov/content/pkg/FR-2010-04-01/pdf/FR-2010-04-01.pdf https://www.govinfo.gov/content/pkg/FR-2010-04-01/xml/FR-2010-04-01.xml fdlp 16325 16639 DGPO 2010-04-01 2024-06-04 FR-2010-04-01 machine generated eng FR FR-2010-04-01 75 62