Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map

FDA announces new User Fee increases for 2004

A few months back we had warned you that the FDA was planning to up their User Fees (FDA Update – June 4, 2003) It seems we were correct in being the first to let you know that there was going to be a user fee increase. But, it seems that, our information was incorrect. Our estimates on the increase were a bit off. We had predicated that the increase would be in the realm of 20%. Wait until you read the increases below and see what the FDA is now up to in putting a real bind on the industry.

The 510(k) and the PMA process just got more expensive, that is starting Oct. 1, 2004. The FDA just announced their increases in the fees they are charging to review these applications for the medical device industry. The increases are quite extensive, though the FDA did go to a two tier 510(k) schedule.

The following is a comparison chart of the old fees and new fees. For 510(k)s the fees are going up 59.1% to $3,480. There will be a discount for the small business owner but that will also be increased to $2784. (a 27.3%).

The FDA has used the following excuse for this raise:

• An increase in the target revenue generated from the user fees of $2,130,000(8.5%)
• An adjustment for inflation of $1,163,789 (Federal pay raise for employees in the Washington DC area was 4.27% the most recent year.)(4.6%), and
• An adjustment to compensate for an unforeseen revenue shortfall in FY 2003 of $5,478,000 (21.8%)

This is the time to speak with your Congressman and complain as to enormous increase in fees.

To see the FDA announcement go the following URL: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01244.html

Or contact mdi directly – info@mdiconsultants.com

.S. AGENT SECTION

Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map