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FDA to Begin Medical Device User Fee Negotiations
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...
FDA Releases Preliminary Evaluations on 510(k) Process
08/04/2010
The FDA released its preliminary report on the 510(k) review process, and provided recommendations on what it believes can be done to improve it. The detailed report included an executive summary...
IOM Hosts 3rd Public Workshop on 510(k) Process
07/30/2010
The Institute of Medicine (IOM) recently hosted its 3rd public workshop in Washington, DC to discuss the 510(k) review process and what potential changes may be needed. There were several...
Senate HELP Committee Holds Panel on Rare Diseases and Medical Devices
07/26/2010
The U.S. Senate HELP Committee held a hearing to promote the development of new treatments and cures for rare pediatric diseases.Minnesota Senator Al Franken spoke about the importance of identifying...
Medical Device Roundtable Event Held in Minnesota
07/12/2010
Congressman Erik Paulsen (MN-03) hosted a roundtable with medical device manufacturers, economic development leaders and others to discuss the current environment for the med tech industry. The...
GPOs Again Under Senate Microscope
07/08/2010
A Washington Monthly front page story in this month's issue details the troubling practices carried out by some Group Purchasing Orders (GPOs), bringing them under new scrutiny. The Wall Street...
EU's Eudamed to be Mandatory in 2011
07/08/2010
A European Commission decision adopted recently will oblige all EU countries to use, as of May 2011, a European databank for medical devices (Eudamed). This secure web-based system is currently being...
New Legislation Introduced to Repeal the Device Tax
06/30/2010
Legislation was introduced this week to repeal the medical device tax and offset its costs by using unspent stimulus funds. The legislation, introduced by Congressman Brian Bilbray (CA-50),...
FDA Hosts Second 510(k) Town Hall Meeting
06/23/2010
The second in a series of public town hall meetings was hosted by the FDA on Tuesday, June 22, 2010 in Woburn, MA.  The meeting was again led by Dr. Jeffrey Shuren, the Director of CDRH, and had...
Institute of Medicine Holds First 510(k) Public Workshop
06/21/2010
The Institute of Medicine’s (IOM) first public workshop to address the effectiveness of the 510(k) review process was held in Washington, DC, and had a large attendance.Dr. Josh Makower, MDMA member...