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Rulemaking » Draft Guidance for Industry and Food and Drug Administration Staff; Availability: Pediatric Information for X-Ray Imaging Device Premarket Notifications
Draft Guidance for Industry and Food and Drug Administration Staff; Availability: Pediatric Information for X-Ray Imaging Device Premarket Notifications
Waiting for the gudiance and the reference material 5/10/2012 (mb)
Document Subtype:
Notice of Availability
Received Date:
May 10 2012, at 12:00 AM Eastern Daylight Time
Start-End Page:
27461 - 27463
Page Count:
3
Comment Start Date:
May 10 2012, at 12:00 AM Eastern Standard Time
Comment Due Date:
September 7 2012, at 11:59 PM Eastern Standard Time
Attachments:
Ref 2 Larson, D.B. et al., Rising Use of CTin Child Visits to the Emergency Department in the United States 1995 2008 Radiology vol 259 3 pp 793 801 2011
View Attachment:
Title: Ref 2 Larson, D.B. et al., Rising Use of CTin Child Visits to the Emergency Department in the United States 1995 2008 Radiology vol 259 3 pp 793 801 2011
Ref 3 The FDA pediatric guidance entitled Premarket Assessment of Pediatric Medical Devices available at
View Attachment:
Title: Ref 3 The FDA pediatric guidance entitled Premarket Assessment of Pediatric Medical Devices available at
Ref 5 The recommendations from pedatric experts at FDA Public Meeting Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging available at Improvements to Reduce Unnecessary Radiation
View Attachment:
Title: Ref 5 The recommendations from pedatric experts at FDA Public Meeting Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging available at Improvements to Reduce Unnecessary Radiation
Ref1 NAS National Research Council Committee to Assess Health Risks from Exposure to Low Levels of Ironizing Radiation Health risks from exposure to low levels of ionizing radiation BEIR VII phase 2 Washington DC National Academy of Sciences National Academies Press 2006
View Attachment:
Title: Ref1 NAS National Research Council Committee to Assess Health Risks from Exposure to Low Levels of Ironizing Radiation Health risks from exposure to low levels of ionizing radiation BEIR VII phase 2 Washington DC National Academy of Sciences National Academies Press 2006
Ref4The FDA Initiative entitled Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging available at
View Attachment:
Title: Ref4The FDA Initiative entitled Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging available at
Draft Guidance for Industry and Food and Drug Administration Staff; Availability: Pediatric Information for X-Ray Imaging Device Premarket Notifications
Details Information
Attachments:
Ref 2 Larson, D.B. et al., Rising Use of CTin Child Visits to the Emergency Department in the United States 1995 2008 Radiology vol 259 3 pp 793 801 2011
View Attachment:Ref 3 The FDA pediatric guidance entitled Premarket Assessment of Pediatric Medical Devices available at
View Attachment:Ref 5 The recommendations from pedatric experts at FDA Public Meeting Device Improvements to Reduce Unnecessary Radiation Exposure from Medical Imaging available at Improvements to Reduce Unnecessary Radiation
View Attachment:Ref1 NAS National Research Council Committee to Assess Health Risks from Exposure to Low Levels of Ironizing Radiation Health risks from exposure to low levels of ionizing radiation BEIR VII phase 2 Washington DC National Academy of Sciences National Academies Press 2006
View Attachment:Ref4The FDA Initiative entitled Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging available at
View Attachment:Comments
View AllPosted: 06/15/2012 ID: FDA-2012-D-0384-0003
Sep 07,2012 11:59 PM ET
Posted: 07/03/2012 ID: FDA-2012-D-0384-0004
Sep 07,2012 11:59 PM ET
Posted: 09/05/2012 ID: FDA-2012-D-0384-0005
Sep 07,2012 11:59 PM ET
Posted: 09/05/2012 ID: FDA-2012-D-0384-0006
Sep 07,2012 11:59 PM ET
Posted: 09/05/2012 ID: FDA-2012-D-0384-0007
Sep 07,2012 11:59 PM ET
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