FDA User Fees Set to Rise in 2019

Posted August 7, 2018

The Food and Drug Administration (FDA) has announced its medical device user fees for fiscal year 2019, running from Oct. 1, 2018 through Sept. 30, 2019. The updates represent an average increase of about 3.7% over the previous fiscal year, a stark contrast from the 33% increase manufacturers faced this time last year.

In 2019, the annual establishment registration fee that must be paid by all medical device manufacturers, regardless of size, will be $4,884. Other updated fees for 2019 include:

  • Premarket application ($322,147, up from $310,764 in 2018)
  • 510(k) premarket notification submission ($10,953, up from $10,566 in 2018)
  • Annual reporting on a Class III device ($11,275, up from $10,877 in 2018)
  • 30-day notice ($5,154, up from $4,972 in 2018)

Qualifying small businesses ($100 million or less in gross receipts or sales) may be subject to reduced rates for certain medical device submissions. The full list of FDA user fees is available on the FDA's website.