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 $24,161 for a small business. This reflects that the de novo is a growing part of the regulatory landscape. It’s a robust and time-consuming review and usually involves clinical data review as well as of course a parallel classification petition.
Some key fees (this year’s fees for standard and small businesses are given below. For the full list see the Federal Register announcement.
|Application fee type||FY 2019 standard fee||FY 2019 small business fee|
|510(k) (De novo)||96,644||24,161|
|Annual establishment registration fee (to be paid by the establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device, as defined by 21 U.S.C. 379i(13))||4,884||4,884|
At these fee levels, small business exemptions really count – and are available to non-US firms too (and the US definition of “Small” is not exactly that small – the concession is available to any firm with <$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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