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Wednesday, June 12, 10:00 am - 11:00 am 
Presenter: Karen Conway, Executive Director, GHX
Level: Intermediate

Orthopaedic manufacturers will be among the first impacted by FDA’s Unique Device Identification rule, which could be final in time for this year’s OMTEC. According to the proposed rule, manufacturers of Class III devices will need to label their products with unique identifiers and be ready to publish data about those products to an FDA UDI database within a year. But UDI is much more than a labeling and data entry exercise. In this session, you will learn what you need to know and do in order to comply, and how to approach the data management challenges in a manner that can drive benefits across your organization and beyond regulatory compliance. Learn, too, how FDA and healthcare systems plan to use the UDI for post-market surveillance and to generate information that can help guide your future product development.

 

Further Topic Resources:
UDI: It's All About the Data