Regulatory Counsel

0910-AH03 201610 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System

The proposed rule would establish special controls for the computed tomography (CT) X-ray system. A CT X- ray system is a diagnostic X-ray imaging system intended to produce cross-sectional images of the body through use of a computer to reconstruct an image from the same axial plane taken at different angles. High doses of ionizing radiation can cause acute (deterministic) effects such as burns, reddening of the skin, cataracts, hair loss, sterility, and, in extremely high doses, radiation poisoning. The design of a CT X-ray system should balance the benefits of the device (i.e., the ability of the device to produce a diagnostic quality image) with the known risks (e.g., exposure to ionizing radiation). FDA is establishing proposed special controls, which are necessary to provide reasonable assurance of the safety and effectiveness of a class II CT X-ray system.

]]> Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes No 21 CFR 892.1750 21 U.S.C. 360c No NPRM 08/00/2017 Yes Businesses None Undetermined No Yes No Erica Payne Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3999 301 847-8145 erica.payne@fda.hhs.gov Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5517, Silver Spring MD 20993