FDA Increases User Fees for 2020


Posted August 2, 2019

The Food and Drug Administration (FDA) has announced increases for its medical device user fees for fiscal year 2020, running from Oct. 1, 2019 through Sept. 30, 2020. The updates represent an average increase of about 6% over the previous fiscal year, when fees increased 3.7%. That is far from the 33% increase manufacturers faced in fiscal year 2018.

In 2020, the annual establishment registration fee that must be paid by all medical device manufacturers, regardless of size, will be $5,236 (including an inflation adjustment), up from $4,884 in 2019.

Other updated fees for 2020 include:

  • Full-fee applications ($340,995, up from $322,147 in 2019)
  • Panel-track supplement ($255,747, up from $241,610)
  • De Novo classification request ($102,299, up from $96,644)
  • 180-day supplements ($51,149, up from $48,322)
  • Real-time supplements ($23,870, up from $22,550)
  • 510(k) premarket notification submission ($11,594, up from $10,953)
  • 30-day notice ($5,456, up from $5,154)
  • 513(g) request for classification information ($4,603, up from $4,349)
  • Annual reporting on a Class III device ($11,935, up from $11,275)
  • Premarket application ($340,995, up from $322,147)

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 in the Federal Register notice.