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User Fee Raise Only Weeks Away!

If you plan to save some money on getting your 510(k) application in prior to the upcoming user fee increase of October 1, 2003, you better get moving.

From our discussions with the FDA, we have determined that you can’t submit your user fee prior to the Oct. 1st date; the 510(k) must also be into the agency prior to that date. In other words, if the 510(k) is not filed prior to the Oct 1st date, the user fee that you submitted prior to that date will not be binding and you will be billed for the additional amount.

You need at least 10 days before the 510(k) is submitted to get the user fee approved. Therefore, if you plan to get your 510(k) in under the present user fee of $2187.00, you must get your user fee in prior to September 20th and have you must have your 510(k) ready for submission as soon as the FDA approves the fee.

If you do get caught with the new user fee of $3480.00, you can petition the FDA - as a small company - and get a fee reduction. Look at the bright side, next year at this time you will find that the user fee of $3480.00 will look good when then next increase will be imposed on an industry made up of over 60% small companies.

For more information on this FDA update contact mdi directly – info@mdiconsultants.com

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