Tag: UDI


FDA UDI Final Rule

Food and Drug Administration The Unique Device Identification (UDI) Final Rule On September 24, 2013, the FDA published a final rule establishing a unique device identification system (the UDI Rule).  The UDI Rule outlines labeling, data submission and standard date formatting requirements for all medical devices in commercial distribution in the U.S., unless an exception or alternative applies. The rule will be

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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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UDI Examples of Medical Devices Under a Voluntary Device Correction

UDI Examples – Compliant or Non-Compliant? CONMED Corporation Issues a Voluntary Device Correction for PadPro and R2 Multi-function Defibrillation Electrodes. The labels of which are examples of UDI implementation by the CONMED Corporation. View more UDI labels of these products here. Compliance Issue The following UDI example is based on the GS1 system of standards.  As for the date format, UDI labels

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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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UDI Compliance Date Extended for Class III Contact Lens and Intraocular Lens Labelers

Extension Letter to Class III Contact Lens and Intraocular Lens Labelers August 15, 2014 FDA issues the following letter. Dear Class III Contact Lens and Intraocular Lens Labelers: Effective August 15, 2014, the FDA’s Center for Devices and Radiological Health (CDRH) is granting a 1-year extension of the September 24, 2014 Unique Device Identification System (UDI) compliance date for the

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DOWNLOAD Unique Device Identification System Small Entity Compliance Guide

By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) and Updated on December 21, 2014 Unique Device Identification System: Small Entity Compliance Guide Guidance for Industry and Food and Drug Administration Staff Document issued on August 13, 2014. Introduction The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary

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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 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 [button url=”http://globalcomplianceseminar.com” target=”blank” style=”3d” background=”#c91119″ size=”10″ wide=”yes” center=”yes”]Learn here about FDA training seminars[/button] Last Updated: 2015-12-29