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 D09002ee1c7fd0aa0 D09002ee1c7fd0b19 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States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Pediatric Information for X-ray Imaging Device Premarket Notifications." This draft guidance document outlines FDA's current thinking on information that should be provided in premarket notifications for x-ray imaging devices with indications for use in pediatric populations. FDA intends for this guidance to minimize uncertainty during the premarket review process of 510(k)s for x-ray imaging devices for pediatric use, to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notifications, and to provide recommendations on information to support such indications. This draft guidance applies only to complete x-ray imaging devices that could be used on pediatric patients. This draft guidance is not final nor is it in effect at this time. 77 FR 27461 https://www.govinfo.gov/app/details/FR-2012-05-10/2012-11260 2012-11260 fr10my12-59 4160-01-P Docket No. FDA-2012-D-0384 https://www.govinfo.gov/app/details/FR-2012-05-10/2012-11260 https://www.govinfo.gov/content/pkg/FR-2012-05-10/html/2012-11260.htm https://www.govinfo.gov/content/pkg/FR-2012-05-10/pdf/2012-11260.pdf 3 p. 27461 27463 77 FR 27461 Draft Guidance for Industry and Food and Drug Administration Staff; Pediatric Information for X-Ray Imaging Device Premarket Notifications; Availability; Federal Register Vol. 77, Issue NOTICE 2012-11260 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2012-D-0384 4160-01-P 2012-11260 Notice.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Pediatric Information for X-ray Imaging Device Premarket Notifications." This draft guidance document outlines FDA's current thinking on information that should be provided in premarket notifications for x-ray imaging devices with indications for use in pediatric populations. FDA intends for this guidance to minimize uncertainty during the premarket review process of 510(k)s for x-ray imaging devices for pediatric use, to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notifications, and to provide recommendations on information to support such indications. This draft guidance applies only to complete x-ray imaging devices that could be used on pediatric patients. This draft guidance is not final nor is it in effect at this time.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 7, 2012. Thalia Mills, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, rm. 4527, Silver Spring, MD 20993-0002, 301-796-6641. Draft Guidance for Industry and Food and Drug Administration Staff; Availability: Pediatric Information for X-Ray Imaging Device Premarket Notifications , dsmica@fda.hhs.gov http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089740.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm300850.htm http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm201448.htm http://www.fda.gov/Radiation-EmittingProducts/RadiationSafety/RadiationDoseReduction/default.htm http://www.regulations.gov 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