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HHS/FDA RIN: 0910-AG78 Publication ID: 2012 
Title: Effective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices 
Abstract: The Food and Drug Administration is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the following two class III preamendments devices: (1) hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis, and (2) hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis. 
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 888.3320; 21 CFR 888.3330 
Legal Authority: 21 USC 360e(b)(1); sec 515(b)(1) of the Federal Food, Drug, and Cosmetic Act; ... 
Legal Deadline:  None
Timetable:
Action Date FR Cite
Withdrawn  11/30/2012   
Regulatory Flexibility Analysis Required: No  Government Levels Affected: State 
Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Michael Ryan
Regulatory Advisor
Department of Health and Human Services
Food and Drug Administration
White Oak, Building 66, Room 1615, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6283
Email: michael.ryan@fda.hhs.gov

 
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