FDA Announces FY05 User Fee Rates
For the second straight year, the Food and Drug Administration has dramatically increased the user fees for reviewing medical technologies. Based on a straight line projection for the last 3 months of the fiscal year, the revenue shortfall from user fees is estimated to be $5.2 million for FY04. In addition, FDA has lowered the estimated number of fee generating submissions they expect to receive from FY05-FY07 without lowering the revenue totals. As a result, industry will be forced to pay more per submission.
The new rates, associated with the Medical Device User Fee and Modernization Act (MDUFMA), were published August 2, in the Federal Register and take effect October 1, 2004. The results are as follows:
| FISCAL YEAR |
2004 |
2005 |
||
| FEE TYPE |
FULL |
SMALL BUSINESS |
FULL |
SMALL BUSINESS |
| Full Fees |
$206,811 |
$78,588 |
$239,237 |
$90,910 |
| 180- Day Supplements |
$44,464 |
$16,896 | $51,436 |
$19,546 |
| Real Time Supplements |
$14,890 |
$5,658 | $17,225 |
$6,546 |
| 510(k)s |
$3,480 |
$2,784 | $3,502 |
$2,802 |
In addition to these
fee increases, the compensating adjustment for the projected
$5.2 million shortfall will not be exercised this year. However,
the current law requires this to be made up by FY07. The result
will be an additional 16% fee increase for both PMAs and 510(k)s
next year on top of any other adjustments.
While we appreciate FDA’s efforts to try and minimize
the impact by delaying the compensating adjustment, this strengthens
our case that legislative modifications are needed to stabilize
the fees permanently. Over the course of just two short years,
the fees have risen over 55%. This simply cannot be sustained
by the innovative sector of the marketplace.
MDMA will continue to seek legislative modifications to MDUFMA
to establish reasonable fees, true enhanced performance from
FDA and additional Congressional appropriations. If these
goals cannot be achieved, we will be forced to let the program
sunset.
FDA presentation (left click mouse to advance slides)
