Tag: Unique Device Identifier


FDA Updates UDI Formats

Food and Drug Administration (FDA) and the Center for Devices and Radiological Health (CDRH)  UDI Formats by FDA-Accredited Issuing Agency November 3, 2015 FDA has accredited three organizations as UDI issuing agencies: GS1 http://www.gs1.org/ Health Industry Business Communications Council (HIBCC) http://www.hibcc.org/ International Council for Commonality in Blood Banking Automation (ICCBBA) https://www.iccbba.org/ This document contains information and links related to the format

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FDA Answers Unique Device Identifier System Questions

By Regulatory Doctor; LinkedIn; Google Plus; Twitter FDA Answers Frequently Asked Questions (FAQs) for Unique Device Identifier System. Section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA, which is downloadable below after registration) and section 614 of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) amended the Federal Food, Drug, and Cosmetic Act to add

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National Medical Device Postmarket Surveillance Plan

National Medical Device Postmarket Surveillance Plan FDA believes that national and international device registries in selected product areas and electronic health information (EHI) containing unique device identifiers (UDI) should serve as the foundation of our National Medical Device Postmarket Surveillance System.  The system could be linked to longitudinal data, such as administrative and claims data, and would employ novel methods for evidence generation,

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FDA Unique Device Identification FDA UDI GS1 Standards

FDA UDI FDA UDI Quick Reference Guide to GS1 Identifiers & Barcodes FDA UDI: Device Identifier (DI) and Production Identifier (PI) UDI: GS1 GTIN or GTIN + GS1 Application Identifier (AI) GTIN*: Global Trade Item Number Download Quick Reference Guide to GS1 Identifiers & Barcodes here. Last Updated: 2015-11-27


FDA Unique Device Identification UDI Application Examples

By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) FDA Unique Device Identification (UDI) Final Rule and GUDID Guidance FDA UDI Information UDI Rule and GUDID Guidance at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#ruleguidance Benefits of Unique Device Identification at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#benefits Compliance Dates for UDI Requirements at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#compliancedates Accredited Issuing Agencies at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#agencies On September 24, 2013, the Food and Drug Administration (FDA) has released a final rule (download it below)

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LIVE Online Seminar Implementing Unique Device Identification Systems


LIVE Seminar for FDA UDI Overview

FDA UDI Final Rule Last Updated: 2015-12-29