EXCLUSIVE Program for IHIF Members Only: 510k Under Assault

Ralph Hall, counsel for Baker & Daniels, will provide a detailed look into the key issues and processes surrounding the changes to the 510(k) system – a key pathway to market for medical devices. The 510(k) system is under unprecedented attack and scrutiny. FDA is completing a 10-month internal review and will announce changes this summer. The Institute of Medicine (IOM) is in the midst of an 18-month assessment of the 510(k) system and whether it provides adequate product safety. Congress is likewise interested in possible changes to the system. Understanding the issues and direction of these efforts is critical for product development and marketing decisions and for investment decisions.

Date:  Thursday, June 17, 2010

Time: 8:00 a.m. – 8:30 a.m. EDT Registration
8:30 a.m. – 10:00 a.m. EDT Programming

Location: Indiana University Emerging
Technologies Center (IUETC)
351 W. 10th Street
Indianapolis, IN 46202

Click here to register.


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