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HHS/FDA RIN: 0910-AH03 Publication ID: Fall 2016 
Title: Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System 
Abstract:

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.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Yes  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 21 CFR 892.1750   
Legal Authority: 21 U.S.C. 360c   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/00/2017 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Erica Payne
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5517,
Silver Spring, MD 20993
Phone:301 796-3999
Fax:301 847-8145
Email: erica.payne@fda.hhs.gov