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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
Timetable:
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
Email: nancy.pirt@fda.hhs.gov

 
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