CT Radiation Dose and Safety: Perspectives at the U.S. Food and Drug Administration

  • Stanley H. Stern
  • Sean Boyd
  • Kish Chakrabarti
  • Iacovos S. Kyprianou
  • Thalia T. Mills
  • David C. Spelic
Part of the Medical Radiology book series (MEDRAD)


With an emphasis on the regulatory framework, we describe three approaches that the U.S. Food and Drug Administration applies to promote dose control and radiation safety in X-ray computed tomography: (1) equipment radiation safety established through consensus standards and regulatory guidance, (2) clinical quality assurance promoted through collaboration with government agencies, industry groups, professional organizations and societies, and outreach to healthcare providers and consumers, and (3) surveillance and improved characterizations of dose and image quality enabled through research.


International Electrotechnical Commission National Electrical Manufacturer Association Compute Tomography Dose Index National Electrical Manufacturer Association Diagnostic Reference Level 



At FDA, contributions to the advancement of radiation safety and effectiveness in CT depend on the efforts of many dedicated people in the CDRH Office of Communication, Education, and Radiation Programs; Office of Science and Engineering Laboratories; and Office of In Vitro Diagnostic Device Evaluation and Safety. We gratefully acknowledge their work.


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Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  • Stanley H. Stern
    • 1
  • Sean Boyd
    • 1
  • Kish Chakrabarti
    • 1
  • Iacovos S. Kyprianou
    • 1
  • Thalia T. Mills
    • 1
  • David C. Spelic
    • 1
  1. 1.U.S. Department of Health and Human ServicesU.S. Food and Drug AdministrationSilver SpringUSA

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