The short answer
FDA publishes new user fees every summer for the fiscal year that starts on October 1. For fiscal year 2027 (October 1, 2026 to September 30, 2027), the fees that matter most to exporters are:
| Fee | FY2027 amount | Who pays |
|---|---|---|
| Medical device annual establishment registration | $13,785 (no small business discount) | Every registered device establishment |
| 510(k) premarket notification | $28,653 standard / $7,163 small business | Each 510(k) |
| De Novo request | $191,020 / $47,755 small business | Each De Novo |
| PMA | $636,732 / $159,183 small business | Each PMA |
| OTC monograph drug facility (MDF) | $47,891 | Owners of OTC monograph drug facilities |
| OTC monograph contract manufacturer (CMO) | $31,927 | Contract manufacturers of OTC monograph drugs |
| VQIP | $9,994 | Importers accepted into VQIP |
| Food reinspection / recall order non-compliance | $325/hour (no travel), $354 (domestic travel), $414 (foreign travel) | Firms that need reinspection or ignore a recall order |
Medical devices (MDUFA)
- The $13,785 establishment registration fee is the same for small businesses. FDA may waive it — except for the initial registration — for a small business with $1 million or less in gross receipts if paying would be a financial hardship.
- Small business rates for premarket submissions apply to businesses (with affiliates) with gross receipts or sales of no more than $100 million; a $30 million threshold applies to the first premarket application fee waiver. You must qualify before you submit.
- Registration must be renewed between October 1 and December 31 each year. See renewal deadlines.
OTC monograph drugs (OMUFA)
- The facility fee applies to each person that owns a facility identified as an OTC monograph drug facility at any time between January 1, 2026 and September 30, 2026.
- For FY2027 FDA split the facility fee into two halves: 50% due October 1, 2026 and 50% due February 1, 2027.
- Facilities that stopped OTC monograph activities and updated their registration before January 1, 2026 are exempt.
- This affects makers of sunscreens, hand sanitizers, antiperspirants, anti-dandruff shampoos and fluoride toothpaste. See NDC numbers for OTC drugs.
Example: a device maker in Germany and a sunscreen factory in South Korea
A German maker of Class I exempt bandages pays the $13,785 FY2027 establishment registration fee and renews its registration before December 31. A Korean factory that makes SPF moisturizers for several brands is an OTC monograph contract manufacturer: it budgets $31,927 for FY2027, paying half by October 1, 2026 and half by February 1, 2027, so its products can keep clearing U.S. customs.
Device registration and U.S. Agent $550 per year, device listing $50 per device. Drug registration, NDC labeler code and U.S. Agent $550 per year, drug listing $350. FDA user fees are paid to FDA separately.
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Frequently asked questions
What is the FDA device registration fee for FY2027?
$13,785 for each establishment, for October 1, 2026 to September 30, 2027. There is no reduced small business rate.
Is there an FDA fee for food facility registration?
No. FDA charges no fee to register or renew a food facility.
What is the OTC monograph facility fee for FY2027?
$47,891 for a monograph drug facility and $31,927 for a contract manufacturing organization, payable in two halves on October 1, 2026 and February 1, 2027.
What is the 510(k) fee for FY2027?
$28,653 standard, or $7,163 for qualifying small businesses.
Sources
- Federal Register — Medical device user fee rates for FY2027 (91 FR 48134, July 30, 2026)
- Federal Register — OTC monograph drug user fee rates for FY2027 (91 FR 48121, July 30, 2026)
- Federal Register — VQIP user fee rate for FY2027 (91 FR 48125)
- Cheese Reporter — FDA raises FY2027 reinspection and recall fee rates (July 31, 2026)
Fees checked on November 12, 2026. This article is general information, not legal advice.