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 2012_register executive 2012-05-10 article Notices D09002ee1c7fd0aa1 D09002ee1c7fd0b1a 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originator org United States Government Agency or Subagency FDA is announcing the following public meeting on the draft guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications." This guidance will apply to x-ray computed tomography, general and dental radiography, and diagnostic and interventional fluoroscopy devices. FDA has organized this meeting to solicit public feedback on the draft guidance and to help identify issues relevant to radiation safety in pediatric x-ray imaging that may benefit from standards development or further research. 77 FR 27463 https://www.govinfo.gov/app/details/FR-2012-05-10/2012-11262 2012-11262 fr10my12-60 4160-01-P Docket No. FDA-2012-N-0385 https://www.govinfo.gov/app/details/FR-2012-05-10/2012-11262 https://www.govinfo.gov/content/pkg/FR-2012-05-10/html/2012-11262.htm https://www.govinfo.gov/content/pkg/FR-2012-05-10/pdf/2012-11262.pdf 5 p. 27463 27467 77 FR 27463 Device Improvements for Pediatric X-Ray Imaging; Public Meeting; Request for Comments; Federal Register Vol. 77, Issue NOTICE 2012-11262 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2012-07-16 Docket No. FDA-2012-N-0385 4160-01-P 2012-11262 Notice of meeting; request for comments.

FDA is announcing the following public meeting on the draft guidance "Pediatric Information for X-ray Imaging Device Premarket Notifications." This guidance will apply to x-ray computed tomography, general and dental radiography, and diagnostic and interventional fluoroscopy devices. FDA has organized this meeting to solicit public feedback on the draft guidance and to help identify issues relevant to radiation safety in pediatric x-ray imaging that may benefit from standards development or further research.

Date and Time: The meeting will be held on July 16, 2012, from 8 a.m. to 5 p.m. Meetings: Device Improvements for Pediatric X-Ray Imaging , Cynthia.Garris@fda.hhs.gov Thalia.Mills@fda.hhs.gov http://edocket.access.gpo.gov/2010/2010-3674.htm http://www.adobe.com/go/connectpro_overview http://www.cdc.gov/nchs/data/nhsr/nhsr010.pdf http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089742.pdf http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm082162.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm300850.htm http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm201448.htm http://www.fda.gov/RadiationEmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/ucm298899.htm http://www.fda.gov/RadiationEmittingProducts/RadiationSafety/RadiationDoseReduction/default.htm http://www.nap.edu/openbook.php?isbn=030909156X http://www.pedrad.org/associations/5364/ig/index.cfm?page=775 http://www.regulations.gov http://www.regulations.gov/#!docketDetail https://collaboration.fda.gov/common/help/en/support/meeting_test.htm Vol. 77, no. 91 Office of the Federal Register, National Archives and Records Administration 2012-05-10 continuing daily deposited born digital 214 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2012-05-10 P0b002ee18266307d 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr10my12 https://www.govinfo.gov/app/details/FR-2012-05-10 https://www.govinfo.gov/content/pkg/FR-2012-05-10/pdf/FR-2012-05-10.pdf https://www.govinfo.gov/content/pkg/FR-2012-05-10/xml/FR-2012-05-10.xml fdlp 27357 27560 DGPO 2012-05-10 2024-06-03 FR-2012-05-10 machine generated eng FR FR-2012-05-10 77 91