The annual establishment registration fee for medical device firms is $13,785 for fiscal year 2027, up from $11,423 in FY2026 — an increase of roughly 20.7%.
FY2027 runs from 1 October 2026 to 30 September 2027. The annual registration period itself runs 1 October to 31 December 2026.
For a manufacturer with a single registered establishment, that is an extra $2,362 against last year. For a firm with several registered sites — a manufacturer, a separate contract sterilizer, a U.S. warehouse — the fee applies per establishment, and the increase compounds accordingly.
The fee comes before the registration
This is the sequencing that trips firms up. FDA requires that the user fee is paid before registration can be completed. Payment generates a Payment Identification Number and a Payment Confirmation Number, and those numbers are what let you complete the registration submission in FURLS.
In practice that means your effective deadline is not 31 December. It is whenever your finance department can process an international payment, plus the time for FDA to reconcile it, plus the submission itself. For firms paying by wire from outside the United States, two weeks is a realistic allowance. Leaving it to the last week of December is how establishments end up unregistered on 1 January.
Small-business status does not reduce this fee
A widespread and expensive misunderstanding. FDA’s Small Business Determination programme reduces fees for premarket submissions — 510(k)s, PMAs and similar — for qualifying firms. It does not offer a reduced rate for the annual establishment registration fee. FDA states plainly that reduced fees are not available for the annual registration fee.
A waiver exists, but it is narrow: it requires gross receipts and sales of $1 million or less including affiliates, together with evidence of financial hardship through active bankruptcy. It is not a small-business discount and very few firms qualify.
So if you hold an SBD certification for your premarket work, budget the full $13,785 per establishment regardless.
Registering is not the same as being cleared
Worth restating because it sits behind a great deal of confusion in the market: establishment registration and device listing tell FDA who you are and what you sell. They are not a review, an approval or a clearance, and a registration number is not evidence that FDA has evaluated your device. Firms that advertise “FDA registered” as though it were “FDA approved” attract warning letters.
What to do this month
- Budget $13,785 per registered establishment for FY2027
- Start the payment process in October — not December
- Confirm your DUNS number and owner/operator account details are current
- Review your device listings alongside the registration
- Foreign establishments: confirm your U.S. Agent designation is current
LMG handles device establishment registration, listing and U.S. Agent representation, and has supported more than 50 successful 510(k) clearances. See Medical Device Registration Renewal or contact our regulatory team.
Related: Medical Device Establishment Registration · Device Registration & Listing Fees · U.S. FDA Agent Service
Sources: FDA, Medical Device User Fee Amendments (MDUFA): Fees; When to Register and List; Reduced or Waived Medical Device User Fees: Small Business Determination (SBD) Program — fda.gov.