top of page

U.S. FDA ANNOUNCES FY2018 USER FEES


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: iuvoleads@iuvoconsulting.com.

Comments


Featured Posts
Recent Posts
Archive
Search By Tags
Follow Us
  • Facebook Basic Square
  • Twitter Basic Square
  • Google+ Basic Square
IUVO_footer_logo.png

About IUVO Consulting

IUVO Consulting, LLC provides expert guidance to help medical device, drug, food and cosmetic companies to achieve and maintain FDA compliance.

Stay Connected

Join our newsletter and stay updated on the latest trends in digital design.

Thanks for submitting!

@2025 IUVO Consulting. All Rights Reserved.

bottom of page