The Final UDI Rule was released in the Code of Federal Regulations on September 24, 2013. This Rule pertains to unique device identification requirements for all medical devices. These requirements pertain to package labeling and direct part marking as well as the UDI database [GUDID].
In this seminar we will review some of the most critical requirements and impacts to medical device manufacturers and to the industry.
Experienced speakers will cover key topics:
* FDA's Final Rule on UDI: Changes from the proposed Rule to Final Rule and important details in the Final Rule
* Impacts related to your choice of Issuing Agency
* Industry challenges presented by the UDI Rule
* How the UDI requirements will impact manufacturers
4:30 - 5:30PM Registration & Social Reception
5:30 - 6:15PM Dinner
Jay Crowley, Senior Advisor for Patient Safety in FDA's Center for Devices and Radiological health, U.S. Food and Drug Administration (FDA),
will review the background of UDI and will address the requirements in the final rule.
MJ Wylie, GS1 U.S. Sr. Director, Healthcare,
will discuss the impact your chosen "Accredited Issuing Agency" will play in your UDI implementation.
Gerry Gunderson, VP of Engineering at Quality Tech Services, will provide a perspective from the manufacturing environment. UDI is not ''just a barcode'' and Manufacturers' compliance will require effort on several fronts including: Developing, imprinting and verifying compliant package barcodes, as well as Direct Part Marking (DPM).
Are you prepared to deal with the impacts of UDI to your business?