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Questions for the Joint Panel Discussion

FDA Office of the Commissioner Joint Meeting of the Gastroenterology-Urology Devices Panel and the Radiological Devices Panel of the Medical Devices Advisory Committee on Computed Tomography Colonography (CTC), September 9, 2013


1. Considering available colorectal cancer screening tools and current colorectal cancer screening recommendations, please discuss the currently available data and information on:

a. The potential benefits of CTC for the screening of asymptomatic patients for colorectal cancer, including test performance characteristics, impact upon overall numbers of patients screened and extracolonic findings; and

b. Safety issues related to the use of CTC for the screening of asymptomatic patients for colorectal cancer, including radiation risk and extracolonic findings.

2. Given the risks and benefits identified, please discuss your views on the role of CTC as one option for screening asymptomatic patients for colorectal cancer.