FDA raises fees 4%

FDA

The new US financial year as always heralds increases in regulatory fees.  FDA published its 2019 fees at end of July. Fees are up around 4% across the board. The cost of a de novo 510(k) now tops out at $96,644 or a still hefty $24,161 for a small business. This reflects that the de novo is a growing part of the regulatory landscape. It’s a robust and time-consuming review and usually involves clinical data review as well as of course a parallel classification petition.

Some key fees (this year’s fees for standard and small businesses are given below. For the full list see the Federal Register announcement.

Application fee typeFY 2019 standard feeFY 2019 small business fee
Premarket Approval$322,147$80,537
510(k) (De novo)96,64424,161
510(k) (traditional)10,9532,738
Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device, as defined by 21 U.S.C. 379i(13))4,8844,884

At these fee levels, small business exemptions really count – and are available to non-US firms too (and the US definition of “Small” is not exactly that small – the concession is available to any firm with <$US100 million turnover). Some tricky paperwork is involved – getting tax statements from the foreign tax authorities and filing with FDA to get small business designation – but it’s worth it!


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