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

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.