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Please note that FDA will consider the 510(k) submission incomplete and will not accept it for filing until the fee is paid in full.

That is, the date of receipt is the date that the submission has been received AND the fee is paid in full.

You should complete the Medical Device User Fee Cover Sheet (Form FDA-3601).

The Medical Device User Fee Cover Sheet and instructions are available online.

FDA will adjust these fees each year to account for inflation, changes in workloads, and other factors. FDA will announce the new fees for the next fiscal year in a Federal Register notice by August 1 of each year.

The following exemptions or waivers apply: Exempt from user fee.

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This application fee applies to most 510(k)s including Traditional, Abbreviated, and Special 510(k)s, but not those exempted or waived as noted below. Payment must be received on or before the time the 510(k) submission is submitted.

You will need to register to create a Medical Device User Fee Cover Sheet.

Please note that the User Fee Cover Sheet website was enhanced on March 1, 2005.

Please note that changing the intended use from pediatric use to adult use requires the submission of a new 510(k).

The new 510(k) is subject to the 510(k) review fee at the time of submission.