On August 3, 2015, FDA announced its new rates for submissions, establishment fees and payment procedures The FDA fiscal year begins October 1st and ends September 30th of the following year.
- Establishment fees went up almost $200.
- Full application fees increase over $10,000.
- Fees to submit a 510(k) Premarket Approval will increase from $5,018 in FY 2015 to $5,228 in FY 2016. This is typically 2% of the standard fee.
You can read the full FY 2016 fee notice, which includes the small business fees and qualification information at: