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FDA USER FEES will not stay at these levels for long.

It appears that there is a little known clause in the User Fee regulations (or as we like to call the User Fee – the 510(k) TAX) concerning the fact that the FDA has the right to raise the fees by 20% a year. There is another little clause that also states that unless Congress meets their commitment of funds the FDA does not have to meet their obligations of productivity for reducing the time for 510(k)s.

This was brought to our attention at a recent meeting with some FDA officials.

From what was explained to me, there is a very good chance, better than a 90% chance to be exact, that the FDA will use their prerogative to raise the User Fees for 510(k) by 20% for the coming fiscal year, 2004.

With this fact in hand, anyone waiting for the upcoming fiscal years to take advantage of the small business discount will end up waiting for no break at all. The discount that is supposed to go into effect for small business is 20% (yes the same rate that the FDA is intending to raise the fee with). So any possible discount will be potentially wiped out by the increase that the FDA can put into effect.

We were told to expect to see the announcement of such a raise in the User Fees in an upcoming Fed Reg.

When we learn more on this we will update you.

.S. AGENT SECTION

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