Member Only Webinar: Unique Device Identification: FDA's Final Rule
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When: 10/2/2013
Where: Online
Presenter: John Manthei & Rebecca Brandt
Contact: Sheri DeVinney

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Nearly six years after the FDA Amendments Act of 2007 directed FDA to establish a unique device identification (UDI) system for medical devices, the Agency has released its final rule implementing the UDI system and a draft guidance addressing the creation of FDA’s Global Unique Device Identification Database (GUDID). In this webinar, John Manthei and Rebecca Brandt of Latham & Watkins LLP will discuss the provisions of the new rule and guidance and examine FDA’s timeline for compliance. Topics covered will include the history and concerns that shaped the rule’s development, changes between the proposed rule issued in 2012 and the final rule, and anticipated FDA follow-up actions of which all medical device companies should be aware.

MDMA Members can view the archived audio version of this webinar or download a PDF version of the webinar slides by clicking here.