Update - January 13, 03

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Update - January 13, 03

On January 6th, the FDA issued a correction and clarification to their USER FEE regulations concerning small businesses.

The major correction and clarification that would immediately effect the small medical device manufacturer is that:

“A small business will pay the full (standard) fee of $2,187 for a premarket notification submitted to FDA during FY 2003. A small business fee, set at 80 percent of the standard 510(k) fee, will be available beginning FY 2004.”

For more information on this correction and clarification visit the FDA website at:

http://www.fda.gov/OHRMS/DOCKETS/98fr/03-494.htm or contact mdi at info@mdiconsultants.com

U.S. AGENT SECTION

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