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08/16/2010

The FDA will hold its first public meeting on September 14, 2010 to begin discussions regarding the reauthorization of medical device user fees. Under provisions of the 2007 legislation, FDA must initiate public meetings well in advance of the January 15, 2012 deadline for its recommendations to Congress. New legislation must be passed before the current program expires on September 30, 2012.

Public comments related to the upcoming meeting are due on October 14, 2010, and will be...

08/04/2010
The FDA released its preliminary report on the 510(k) review process, and provided...
07/30/2010
The Institute of Medicine (IOM) recently hosted its 3rd public workshop in...
07/26/2010
The U.S. Senate HELP Committee held a hearing to promote the development of new...
07/12/2010
Congressman Erik Paulsen (MN-03) hosted a roundtable with medical device...
07/08/2010
A Washington Monthly front page story in this month's issue details the troubling...