Unique Device Identification System

Document ID: FDA-2011-N-0090-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Administrative Practices and Procedures
Federal Register Number: 2012-16621
CFR Citation: 21 CFR Parts 16, 801, 803, 806, 810, 814, 830
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Details Information

Abstract: Waiting for Reference 11 from John Maiers
Document Subtype: Notice of Proposed Rulemaking (NPRM)
Received Date: July 10 2012, at 12:00 AM Eastern Daylight Time
Start-End Page: 40735 - 40778
Page Count: 44
Comment Start Date: July 10 2012, at 12:00 AM Eastern Standard Time
Comment Due Date: November 7 2012, at 11:59 PM Eastern Standard Time

Attachments:

Index to References

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Ref 3 Econ_formatted for pdf_Trade Data_

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Ref 9 Econ Leape-IOM 2007 Ref 15

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Ref 10 Econ EPA FAQ Mortality risk valuation

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Ref 2 Econ_formatted for pdf_Device trade 2007-09

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Ref 4-1 Econ--ISIC data for medical instruments xls

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Ref 5 Econ Furukawa 2008

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Ref 6 Econ Hefflin_2007

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Ref 7 Econ Samore_2004

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Ref 8 Econ Bright_2007

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Reference 1 Referenced ISO standards and ISO Technical Committees

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Reference 1 Econ ERG-UDI FinalMay-14-2012

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Reference 10 UDI Preliminary Regulatory Impact Analysis (RIA)

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Reference 11 Supporting Statement for Unique Device Identification UDI System 21 CFR Pars 801 803 806 810 814 820 821 822 and 830 OMB No 0910

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Reference 2 Information about UPC and other barcodes and GS1

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Reference 3 The Health Industry Bar Code (HIBC) Supplier Labeling Standard

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Reference 4 White Paper - Automatic Identification of Medical Devices

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Reference 5 Record and public comments related to the October 25 2006 and February 12 2009 public meetings

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Reference 6 ERG Final Report - Unique Identification for Medical Devices

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Reference 7 Information concerning HL7 implementation of SPL model for medical product information

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Reference 8 Letter from Michael D Maves AMA

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Reference 9 Class I GMP-Exempt Devices by Procode

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Supporting Statement for Unique Device Identification (UDI) System 21 CFR Pars 16 801 803 806 810 814 820 821 822 and 830 OMB No 0910

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Comments

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Total: 228
Donald Watson - Comment
Posted: 07/19/2012     ID: FDA-2011-N-0090-0005

Nov 07,2012 11:59 PM ET
Steven Edward Smith - Comment
Posted: 08/07/2012     ID: FDA-2011-N-0090-0006

Nov 07,2012 11:59 PM ET
Beverly Anne Stefanavage - Comment
Posted: 08/07/2012     ID: FDA-2011-N-0090-0008

Nov 07,2012 11:59 PM ET
Marie Louise Corner - Comment
Posted: 08/07/2012     ID: FDA-2011-N-0090-0009

Nov 07,2012 11:59 PM ET
Michael Falco - Comment
Posted: 08/07/2012     ID: FDA-2011-N-0090-0010

Nov 07,2012 11:59 PM ET

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