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HHS/FDA RIN: 0910-AC34 Publication ID: Fall 2005 
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: Completed Actions 
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
Action Date FR Cite
NPRM  12/10/2002  67 FR 76056   
Final Action  06/10/2005  70 FR 33998   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Nancy Pirt
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, WO 66, Room 4438, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6248
Fax:301 847-8145

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