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FDA releases Fiscal Year 2016 fee schedule

August 4, 2015

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:

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

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