At Medreg, we assist eligible medical device businesses in applying for FDA Small Business Determination to access applicable user fee reductions or waivers. Our support includes guidance on eligibility criteria, preparation of the Small Business Request (SBR), completion of Form FDA 3602 (U.S. businesses) or Form FDA 3602A (businesses outside the U.S.), and compilation of the required financial documentation, including information on affiliates, in accordance with FDA requirements.

The applicable threshold depends on the benefit being sought. See below for additional details on eligibility:

$100 million or less — Reduced Application/Report Fees
$30 million or less — First Premarket Application/Report Fee Waiver
$1 million or less — Annual Registration Fee Waiver (where paying the fee would be a financial hardship, as determined by FDA)