How much does FDA registration cost?
The FDA annual medical-device establishment registration fee is $11,423 for FY 2026, which runs from October 1, 2025, through September 30, 2026. The fee increases to $13,785 for FY 2027, beginning October 1, 2026.
Answer
FDA medical-device registration cost depends on the fiscal year and the number of establishments requiring registration. Each registrable establishment generally pays the full annual establishment-registration fee:
FY 2026: $11,423
FY 2027: $13,785
The FY 2026 amount applies through September 30, 2026. A registration renewed after October 1, 2026, for FY 2027 is therefore subject to the $13,785 fee, even though the renewal occurs during calendar year 2026.
The establishment fee is separate from premarket-submission fees. For FY 2026, FDA lists a standard 510(k) fee of $26,067, a De Novo fee of $173,782, and a PMA fee of $579,272. Qualified small businesses may receive reduced application fees, but small-business status does not ordinarily create an automatic reduced establishment-registration rate.
A company with several registrable manufacturing, sterilization, or processing facilities may owe a separate establishment fee for each facility. Additional compliance costs can include testing, quality-system implementation, U.S.-agent services, technical documentation, submission preparation, labeling work, and post-market activities.
Current amounts should always be confirmed on the FDA MDUFA fee page before payment because the fees are adjusted annually.
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