Docket Management
Docket: 02N-0534 - Medical Device User Fee and Modernization Act of 2002
Comment Number: EC -2

Accepted - Volume 1

Comment Record
Commentor Mr. Richard Voelker Date/Time 2003-02-07 08:58:15
Organization Ridge Products Inc.
Category Company

Comments for FDA General
1. General Comments After being in the medical industry for 25 years as a contract manufacturer I have been forced to decide whether to close my doors due to offshore manufacturing competition, primarily Mexico. My new game plan was to create a small line of 3-4 products and sell direct into niche areas of the market. The new users fees would make this impossible for me. The mear cost of developing 510k(s) for approval of substancially equivalent items is enough in itself. We would most likely only have sales under 1 million dollars. The new users fees would eliminate the ability for small companies and start ups to exist. Only again allowing the big companies to prevail and eliminating their need to create more cost effective products by the simple elimination of the small business. I beleive the fee program defines a small business as 30 million in sales or less to get a small discount at best on the fees. I think that is absurd being that more than 50% of us only do 1-4 million at best. I believe that the users fees rates need to be exempt to such small companies. A simple application form and proof of income is all that would be necessary to enable a company to apply for user fee exemption. I have looked at the user fee schedule and to a large company this is simply a drop in the bucket, but to the majority of us operating small business it means a second mortgage.I really understand the need for these fees to help offset a portion of the cost involved for reviewing submissions, but also hope that the FDA understands the need for small business to survive might depend on having to pay these fees. Thank you.

EC -2