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Academic Radiology
Volume 17, Issue 5
, Pages 652-657
, May 2010
FDA & Digital Mammography: Why Has FDA Required Full Field Digital Mammography Systems to Be Regulated as Potentially Dangerous Devices for More Than 10 Years?
References
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- US Food and Drug Administration. Premarket applications for digital mammography systems; final guidance for industry and FDA. Available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073624.htm. Accessed February 9, 2010.
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- US Food and Drug Administration. FY 2010 all purpose table—budget authority. Available at: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM153876.pdf. Accessed February 9, 2010.
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Mr Nields is chairman of Bioptics Inc, a company developing complementary metal-oxide semiconductor technology for applications that include full-field digital mammography.
PII: S1076-6332(10)00065-6
doi: 10.1016/j.acra.2010.01.012
© 2010 AUR. Published by Elsevier Inc. All rights reserved.
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Academic Radiology
Volume 17, Issue 5
, Pages 652-657
, May 2010
