Steep rise in FDA fees for 2025-2026

Alert 🫰 Steep rise in FDA fees from this October:

+19% Annual establishment registration fee from $9,280 to $11,423 (this is the one you pay every year for keeping the right to place a device on the market)

+7% Application fees, e.g. 510k submission from $24,335 to $26,067 (this is the one-off fee for review of a product submission file)

Bad news for early stage medtech businesses and SMEs, in particular since no "small business discount" nor waivers apply on the establishment fee at first registration.

Note, small businesses may qualify for waiver on the establishment fee (2nd year on) and a reduced application fee (e.g. 510k for $6,517 instead of $26,067, new fees) under the SBD programme. Conditions are based on gross sales and justification of "financial hardship", rather than on company size. Worth looking into.

See latest MDUFA fees on the FDA website at this link.