Registration Fees & MDUFA Payment
Fee authority
Annual establishment registration fees are authorised by the Medical Device User Fee Amendments (MDUFA). Fees are set annually by FDA and are published in the Federal Register each October for the following fiscal year (October 1 – September 30).
FY2026 fee (approximate)
| Fee type | Amount (FY2026) |
|---|---|
| Standard establishment registration | ~$7,653 |
| Small business establishment registration | ~$1,913 |
Exact fees are published by FDA annually — check the FDA user fee website for the current year's amounts.
Small business qualification
A small business for MDUFA registration fee purposes is an entity with annual gross receipts or sales ≤ $100 million (including affiliates). Small businesses may qualify for a reduced registration fee.
Payment process
Registration fees are paid through FDA's FEE system (Federal eCopy Electronic Fee) during the FURLS registration/renewal process. Payment is required to complete registration.