Originally Published MX
Originally Published MX September/October 2003
|Comparison of FDA medical device user fee rates for FY03 and FY04. (Click to enlarge).|
Industry controversy over FDA's medical device user fee program may have taken a holiday for much of FY03, but nothing could have been more calculated to rekindle the flames than the agency's fee hikes recently announced for the coming year.
In FY04, the full rate for premarket notifications (510(k)s) will increase by nearly 60%, rising to $3480 for each submission. However, small businesses will retain some advantages, with their rate for 510(k) submissions increasing by only 27.3%, to $2784 (see Table).
The new rates are part of an overall 34.9% increase in medical device user fees for the coming fiscal year. The adjusted rates are effective October 1, 2003.