Every year on October 1 FDA resets its medical device user fees. For fiscal year 2027, which runs from October 1, 2026 to September 30, 2027, the annual establishment registration fee is $13,785. For most foreign device manufacturers this is the one fee that comes back every year, whatever happens with new products, and it must be paid before the registration can be completed. Here is what the FY 2027 numbers mean in practice.
FY 2027 device user fees at a glance
- Annual establishment registration: $13,785. There is no reduced small-business rate for this fee.
- 510(k) premarket notification: $28,653 standard, $7,163 for qualified small businesses.
- 513(g) request for classification information: $8,596 standard, $4,298 small business.
- De Novo classification request: $191,020 standard, $47,755 small business.
- PMA, PDP, PMR or BLA: $636,732 standard, $159,183 small business.
Small-business rates apply only to firms that CDRH has qualified through its Small Business Determination (SBD) program for the current fiscal year. No user fee applies to a 510(k) submitted to FDA through an FDA-accredited third-party reviewer.
Who has to pay the establishment fee
Most establishments that must register with FDA also pay the annual fee. For foreign companies this typically includes manufacturers, specification developers, contract manufacturers and sterilizers, relabelers and repackagers, and foreign exporters of devices made elsewhere. Some registered activities do not carry the fee, so check your exact activity against FDA's "Who Must Register, List and Pay the Fee" table before you pay. Our guide to medical device registration for foreign manufacturers explains the activity types in more detail.
FDA may waive the annual establishment fee, but not the fee for an initial registration, for certain small businesses that qualify through the SBD program and show that paying it would cause financial hardship. The waiver is decided by FDA case by case. You should not assume you have one.
The annual registration window: October 1 to December 31
Device establishments renew their registration and review their device listings every year between October 1 and December 31. The sequence matters: pay the FY 2027 fee first through FDA's Device Facility User Fee system, receive the payment identification number, then complete the annual registration in FDA's Unified Registration and Listing System (FURLS). Paying the fee alone does not renew a registration. A registration that is not renewed by December 31 can make the establishment's devices misbranded, which can lead to products being held at the US border.
US Agent and listing requirements
A foreign establishment that must register must also name a US Agent who lives in, or has a place of business in, the United States. FDA uses the US Agent to contact the establishment and to schedule inspections, so the agent must be reachable and must confirm the appointment. Our article on why every foreign facility needs a US Agent explains the role. Device listings should also be checked each year: add new products, remove discontinued ones and confirm the product codes.
Registration is not clearance
Paying the fee and registering does not mean FDA has approved or cleared a device. Many Class II devices also need a 510(k), and higher-risk devices need a De Novo or PMA, each with its own fee shown above. Labels must also meet FDA's rules. Our guide to medical device labeling symbols for the US market explains which symbols can be used without accompanying text.
FY 2027 checklist for foreign device manufacturers
- Confirm your registered activity and whether it carries the establishment fee.
- Budget $13,785 for the FY 2027 establishment fee, and pay it through the Device Facility User Fee system before you register.
- Complete the annual registration and listing review in FURLS between October 1 and December 31, 2026.
- Confirm that your US Agent details are current and that the agent has accepted the appointment.
- If you plan a 510(k), De Novo or PMA this year, apply for small-business qualification first. It can reduce those fees by about three quarters.
FDABridge handles medical device establishment registration, device listing and US Agent designation for foreign manufacturers. The FDA fee is paid to FDA and is separate from FDABridge's service fee.
Sources
- FDA, Medical Device User Fee Amendments (MDUFA) Fees: https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees
- 21 CFR Part 807, Establishment Registration and Device Listing: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-807