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HHS/FDA RIN: 0910-AC34 Publication ID: Fall 2004 
Title: Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major Components 
Abstract: This rule amends the performance standard for diagnostic x-ray systems and their components in 21 CFR 1020.30, 1020.31, 1020.32, and 1020.33 to address the changes in technology and practice. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: No 
CFR Citation: 21 CFR 1020.30    21 CFR 1020.31    21 CFR 1020.32    21 CFR 1020.33   
Legal Authority: 21 USC 351    21 USC 352    21 USC 360e to 360j    21 USC 360hh to 360ss    21 USC 371    21 USC 381   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  12/10/2002  67 FR 76056   
Final Action  12/00/2004    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Joseph M. Sheehan
Chief, Regulations Staff
Department of Health and Human Services
Food and Drug Administration
HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive,
Rockville, MD 20850
Phone:301 827-2974
Fax:301 594-4765
Email: joseph.sheehan@fda.hhs.gov