Final Rule on UDI 9-23-2013.pdf

download Final Rule on UDI 9-23-2013.pdf

of 44

Transcript of Final Rule on UDI 9-23-2013.pdf

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    1/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    2/44

    mailto:[email protected]

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    3/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    4/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    5/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    6/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    7/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    8/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    9/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    10/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    11/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    12/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    13/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    14/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    15/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    16/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    17/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    18/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    19/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    20/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    21/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    22/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    23/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    24/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    25/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    26/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    27/44

    http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htmhttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htmhttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htmhttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htmhttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htmhttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htmhttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htm

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    28/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    29/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    30/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    31/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    32/44

    http://wiki.hl7.org/index.php?title=Medical_Product_Information_(SPLr5)http://wiki.hl7.org/index.php?title=Medical_Product_Information_(SPLr5)http://wiki.hl7.org/index.php?title=Medical_Product_Information_(SPLr5)http://www.regulations.gov/http://www.regulations.gov/http://www.gs1us.org/standards/barcodeshttp://www.gs1us.org/standards/barcodeshttp://www.hibcc.org/publication/view/supplier-labeling-standard/http://www.hibcc.org/publication/view/supplier-labeling-standard/http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm054169.htmhttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm054169.htmhttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm054169.htmhttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm054169.htmhttp://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    33/44

    http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htmhttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htmhttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htmhttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htmhttp://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM310427.pdfhttp://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM310427.pdfhttp://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM310427.pdfhttp://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/UCM310427.pdfhttp://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    34/44

    mailto:[email protected]:[email protected]

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    35/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    36/44

    mailto:[email protected]

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    37/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    38/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    39/44

    http://webstore.ansi.org/http://webstore.ansi.org/http://www.standardsinfo.net/http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.htmlhttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.htmlhttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.htmlhttp://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    40/44

    mailto:[email protected]

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    41/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    42/44

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    43/44

    mailto:[email protected]://www.fda.gov/udi/http://www.fda.gov/udi/http://www.fda.gov/udi/

  • 8/10/2019 Final Rule on UDI 9-23-2013.pdf

    44/44


UDI Benefits - UDI Conference 2021€¦ · 04/04/2016  · UDI Benefits. April 19, 2016. Nancy LeMaster, BJC HealthCare. Dave Reed, Cook Medical. Slide 2. UDI vs. GS1 Standards. ...

UDI Benefits - UDI Conference 2021€¦ · 04/04/2016  · UDI Benefits. April 19, 2016. Nancy LeMaster, BJC HealthCare. Dave Reed, Cook Medical. Slide 2. UDI vs. GS1 Standards. ...

AADHAAR (UDI)

AADHAAR (UDI)

FDA’s Unique Device Identification (UDI) System –The Final ... · Final rule – a combination product must have a UDI: • If it does, the device constituent parts are exempt.

FDA’s Unique Device Identification (UDI) System –The Final ... · Final rule – a combination product must have a UDI: • If it does, the device constituent parts are exempt.

FREYR UDI VISION SERIES SESSION 1 - UDI READINESS

FREYR UDI VISION SERIES SESSION 1 - UDI READINESS

The Worldwide Melding of Regulatory ... - UDI Conference 2021...Jun 06, 2019  · Harmonization of UDI-DI triggers and other multiple UDI-DI use cases Use of UDI along supply chain

The Worldwide Melding of Regulatory ... - UDI Conference 2021...Jun 06, 2019  · Harmonization of UDI-DI triggers and other multiple UDI-DI use cases Use of UDI along supply chain

UDI SCSI Drivers

UDI SCSI Drivers

Rule 23 @ 50: The 50th Anniversary of Rule 23 Rule 23@50... · Rule 23 @ 50: The 50th Anniversary of Rule 23 ... Good morning again, ... I was very lucky to have Benjamin Kaplan as

Rule 23 @ 50: The 50th Anniversary of Rule 23 Rule 23@50... · Rule 23 @ 50: The 50th Anniversary of Rule 23 ... Good morning again, ... I was very lucky to have Benjamin Kaplan as

Udi comarca

Udi comarca

UDI 6º Carballal

UDI 6º Carballal

p36.labs UDI Platform Factsheet · Unique Device Identification (UDI) now and in future. The UDI Platform by p36.labs tackles the challenge of global UDI compliance with a unique

p36.labs UDI Platform Factsheet · Unique Device Identification (UDI) now and in future. The UDI Platform by p36.labs tackles the challenge of global UDI compliance with a unique

Unique Device Identification UDI Requirements and Timelines · UDI final rule was released and we were all happy to see that eventually hit the federal register. In concert with that

Unique Device Identification UDI Requirements and Timelines · UDI final rule was released and we were all happy to see that eventually hit the federal register. In concert with that

UDI Regulatory Basics

UDI Regulatory Basics

UDI – Final rule Final rule - Loopiamedia.qadvis.com.loopiadns.com/2016/...Seminar-Lund... · UDI – Final rule Ferenc Dahnér QAdvis D QAdvis AB Lund vi d - i A Stockholm ...

UDI – Final rule Final rule - Loopiamedia.qadvis.com.loopiadns.com/2016/...Seminar-Lund... · UDI – Final rule Ferenc Dahnér QAdvis D QAdvis AB Lund vi d - i A Stockholm ...

AIDC Session UDI - GS1 · Self exempt and document in Design History File. ... FDA „Final Rule“ UDI Product must be labeled with UDI ... (row/column) sGTIN with minimum ...

AIDC Session UDI - GS1 · Self exempt and document in Design History File. ... FDA „Final Rule“ UDI Product must be labeled with UDI ... (row/column) sGTIN with minimum ...

Strategies for meeting FDA's UDI Rule

Strategies for meeting FDA's UDI Rule

Présentation PowerPointekladata.com/FoMNTzqwBWfArSMW7jy2OyWayWE/poutre-du-temps...Juin 2020 17 18 19 20 21 22 23 24 25 26 edi udi edi di he Lundi di edi udi ETE Commémoration de

Présentation PowerPointekladata.com/FoMNTzqwBWfArSMW7jy2OyWayWE/poutre-du-temps...Juin 2020 17 18 19 20 21 22 23 24 25 26 edi udi edi di he Lundi di edi udi ETE Commémoration de

UDI GLOBAL HARMONIZATION

UDI GLOBAL HARMONIZATION

UDI LABELINGqls.astronovaportal.com/common/white-papers/QuickLabel-UDI-Label… · The Food and Drug Administration’s Unique Device Identification (UDI) System is a new rule that

UDI LABELINGqls.astronovaportal.com/common/white-papers/QuickLabel-UDI-Label… · The Food and Drug Administration’s Unique Device Identification (UDI) System is a new rule that

Implementation of UDI In the Medical Device Industry · UDI Guidance Provided by FDA as a Result of Collaboration and Adjudication Process UDI GUIDANCE DOCUMENTS ISSUED by FDA UDI

Implementation of UDI In the Medical Device Industry · UDI Guidance Provided by FDA as a Result of Collaboration and Adjudication Process UDI GUIDANCE DOCUMENTS ISSUED by FDA UDI

AN OVERVIEW OF GLOBAL UNIQUE DEVICE IDENTIFICATION (UDI) · UDI-DI (Device Identifier) UDI-PI (Production Identifier) The UDI-DI is a unique numeric or alphanumeric code specific

AN OVERVIEW OF GLOBAL UNIQUE DEVICE IDENTIFICATION (UDI) · UDI-DI (Device Identifier) UDI-PI (Production Identifier) The UDI-DI is a unique numeric or alphanumeric code specific