COSTS

The Medical Device User Fee and Modernization Act of 2002 outlines new user fee payment procedures for applicants seeking market approval. The increased fees outlined by the Act are significant, must be paid at the time of submission, and the payment process involves jumping through some hoops.

If you qualify as a small business the application fees are either reduced or waived. A small business is one that reports gross receipts or sales of no more than $30 million. You must include in that calculation the receipts of any affiliate, partner, or parent firms and such receipts will be counted in determining your small business status. This is something to keep in mind when structuring your company because the cost increases are significant for larger businesses. The FDA waives the PMA fee for Small Businesses filing their first PMA, but not if your affiliates or partners have filed a PMA in the past.

In reviewing the fees in Table 3, note that 180-Day Supplements may outline a significant change in components, materials, design, specification, software, color additives, or labeling to your already approved PMA. Real-Time Supplements cover minor changes.

ABOUT THE AUTHOR

Christopher P. Pimentel, Esq., Vice President, Project Development, Lexten Inc.

Mr. Pimentel has experience with government proposals and performance contracts, licensing & contract management, technology evaluation, project management, stock purchase & corporate governance. He was a cofounder and Executive Vice President of Crosslink Medical, where he became interested in medical devices. Mr. Pimentel also served as Assistant Agreements Specialist at Massachusetts General Hospital's Corporate Sponsored Research and Licensing and was a finalist in the 2002 MIT 50k Entrepreneurship Competition.