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Search Keyword: unique device


FDA Guidance Outlines How to Create a Unique Device Identifier

by Carolyn LaWell | Jul 2016 (Legal, Clinical & Regulatory) FDA recommends companies reexamine UDI basics with new draft guidance on how to form a proper identifier. As you prepare for another Unique Device Identification deadline in September, be aware that ... Read more »

Unique Device Identification (UDI): Many Questions Remain

by Karen Conway | Dec 2014 (Legal, Clinical & Regulatory) ...  More than one year after FDA issued its final rule requiring medical device manufacturers to assign and label products with unique device identifiers (UDIs) and publish additional data about those products ... Read more »

FDA Announces Final Rule for Unique Device Identification System

by BONEZONE | Sep 2013 (Supplier News Items) FDA announced a final rule for the Unique Device Identification (UDI) system. Of note, Class III devices will be required to carry UDI on labels/packaging within 1 year, and FDA has eliminated the requirement ... Read more »

Unique Device Identification: From Compliance to Value

by Karen Conway | Oct 2012 (Supply Chain Management) It took five years, but the U.S. FDA has finally issued the proposed Unique Device Identification rule that will require manufacturers of medical devices to uniquely identify their products and populate ... Read more »

FDA Releases AI Action Plan for Medical Devices

by Patrick McGuire | Jan 2021 (Legal, Clinical & Regulatory) ... devices. In acknowledging unique patient issues and concerns involved with AI and ML’s integration into medical devices, such as usability, equity, trust and accountability, FDA doubled down on its commitment ... Read more »