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HHS/FDA RIN: 0910-AG31 Publication ID: Spring 2011 
Title: Unique Device Identification 
Abstract: The Food and Drug Administration Amendments Act of 2007 (FDAAA), amended the Federal Food, Drug, and Cosmetic Act by adding section 519(f) (21 U.S.C. 360i(f)). This section requires FDA to promulgate regulations establishing a unique identification system for medical devices requiring the label of medical devices to bear a unique identifier, unless FDA specifies an alternative placement or provides for exceptions. The unique identifier must adequately identify the device through distribution and use, and may include information on the lot or serial number. 
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: Undetermined 
CFR Citation: 21 CFR 16; 21 CFR 801; 21 CFR 803; 21 CFR 806; 21 CFR 810; 21 CFR 814; 21 CFR 820; 21 CFR 821; 21 CFR 822 
Legal Authority: Not Yet Determined 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  09/00/2011   
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
Agency Contact:
John J. Crowley
Senior Advisor for Patient Safety
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, WO 66, Room 2315, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 980-1936
Email: jay.crowley@fda.hhs.gov

 
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