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FDA Announces New Goal for Reducing Total Device Review Times

The FDA announced that they were raising the User Fees (tax) on PMAs and 510(k)s just last month. Now the FDA is announcing the reduction in time goals that they are trying to achieve as a result of this increase in this imposed tax. 

The FDA goes on to state that their goal between 2005 – 2007, which is to reduce the time by 30 days for the fastest 50% of the applications approved.  

I guess that you could say that a fee of over $200,000. is worth maybe 30 days. But, be aware that by 2005 the fee will probably be over $250,000. for each PMA. 

Interesting enough, the FDA does not have any goal for reducing the time for the 510(k) applications. I guess a tax of over $3000. in User Fees is worth nothing. (Remember that the $3000. fee is for 2004 Fiscal Year and it will go higher.) 

For more information on this go to the FDA website at: http://www.fda.gov/bbs/topics/NEWS/2003/NEW00929.html

Or contact mdi directly – info@mdiconsultants.com

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