Using Recall Data to Analyze the 510(k) System
A LifeScience Alley Featured Program
8/12/2010 |
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Time
Registration: 7:30 am - 8:00 am
Program: 8:00 am - 10:00 am
Event Description
Please note extended program time. We've extended this program 30 minutes to include Ralph Hall's initial analysis of the Recommendations of the FDA 510(k) internal Working Group.
Follow this link to view the CDRH Preliminary Internal Evaluations.
Professor Ralph Hall of the University of Minnesota Law School and counsel to the firm of Baker & Daniels has recently completed the first major study assessing the 510(k) system from a safety perspective. Hall's work is being presented to the IOM committee reviewing the 510(k) system and to various congressional offices. At this LSA program, Hall will review his research and the message his research has for potential changes to the 510(k) system.
Substantial time and energy has been devoted to debating changes to the 510(k) system. However, there had been no systemic, data based assessment of whether the 510(k) system has permitted some inordinate number of products onto the market. This seminal study provides vital guidance for decision makers.
Speakers
Ralph F. Hall, JD, Counsel, Baker & Daniels LLP
Ralph F. Hall, JD has extensive experience in the areas of FDA, health care law and corporate compliance, including the application of those regulatory (more)
Topics
The following topics will be addressed:
Location
Risdall Marketing Group, LLC Map