FDA releases Fiscal Year 2016 fee schedule

On August 3, 2015, FDA announced its new rates for submissions, establishment fees and payment procedures The FDA fiscal year begins October 1^st and ends September 30^th  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:

https://www.federalregister.gov/articles/2015/08/03/2015-18907/medical-device-user-fee-rates-for-fiscal-year-2016#page-46036

FY 2015 fees are at: https://www.federalregister.gov/articles/2014/07/30/2014-17902/medical-device-user-fee-rates-for-fiscal-year-2015