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The #USFDA just announced its #UserFees for FY2018, and there are some MAJOR increases. If your company is planning to submit a 510(k) or de novo submission after October 1, you'll see the biggest jump in fees. To submit a #510k #PreMarketNotification, companies will pay $10,542 ($2,636 for small businesses). Moreover, there is now a fee for #DeNovoSubmissions: $93,017 ($23,254). These are major increases for businesses without small business designation, since the 510(k) was less than $5,000 in FY2017, and no fee was previously been associated with de novo submissions.

Other fees for #FY2018, charged by the agency, include the following:

510(k) $10,542 $2,636 513(g) $4,186 $2,093 De Novo classification $93,017 $23,254 PMA, PDP, PMR, BLA $310,058 $77,515 panel-track supplement $232,544 $58,156 180-day supplement $46,509 $11,627 real-time supplement $21,704 $5,426 BLA efficacy supplement $310,058 $77,515 PMA annual report $10,852 $2,713 30-day notice $4,961 $2,481

IUVO Consulting, LLC helps companies comply with FDA requirements. If you need help qualifying as a FDA-recognized small business, or if you need help with a 510(k), #513g, or de novo submission, contact us today:

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