510(k) Reform – Using Recall Data to Analyze the 510(k) System
While much has been debated in the 510(k) realm, we have yet to see true statistical data – until now. Ralph Hall, counsel for Baker & Daniels, recently completed the first major study examining the 510(k) system. This presentation, which is sponsored by IHIF, IMDMC and Baker & Daniels LLP, will provide a detailed look into his research and the resulting potential implications for the 510(k) system.
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. Hall’s work will be presented to the IOM and those Congressional offices interested in possible changes to the system. Hall’s study will provide the aforementioned policy makers with the critical data they need to make 510(k) guidance decisions.
Date: Wednesday, September 15, 2010
Time: 8:00 a.m. EDT I Registration
8:30 a.m. – 10:00 a.m. EDT I Programming
Location:
Indiana University Emerging Technologies Center (IUETC)
351 W. 10th Street
Indianapolis, IN 46202
Registration Fee: $25 for IHIF and IMDMC members, $75 for non-members
Please bring your check (payable to “IHIF”) to registration on the day of the presentation.
