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FDA Medical Device Registration Fee for 2027

Unlike food and cosmetic registration, medical device registration comes with a large annual FDA fee. Here is what it is for fiscal year 2027 and how it works.

Updated November 2026By Regovant LLC4 min read

The fee for fiscal year 2027

Annual establishment registration fee$13,785
Fiscal yearOctober 1, 2026 to September 30, 2027
Small business rateNone. The fee is the same for every establishment.
Paid toFDA directly, not to your consultant or agent

FDA sets the fee by law every year, and it applies to each registered establishment. FDA can waive the annual fee only in limited cases, for small businesses that show financial hardship.

When it is due

  • New establishments: before registering, which must be done within 30 days of starting an activity that requires registration.
  • Existing establishments: every year before renewing, between October 1 and December 31.

How payment works

  1. Create a payment in FDA's Device Facility User Fee system.
  2. Pay FDA by card, bank transfer or another accepted method.
  3. Get your PIN and PCN. FDA issues a payment identification number and a payment confirmation number.
  4. Register. The PIN and PCN are entered in the registration to show the fee is paid. Without them, the registration is not complete.
Pay early in the renewal window. Payment confirmation can take a few days, and an unpaid fee means the registration is not renewed.

Other FDA device fees

Premarket submissions have their own fees. For fiscal year 2027, a 510(k) costs $28,653, or $7,163 for qualifying small businesses. See device registration vs 510(k).

Questions

Is FDA's fee included in Regovant's price?

No. You pay FDA's fee directly. Our $369 a year covers registration, listing support and U.S. Agent service, and we send you step-by-step payment instructions.

Does every establishment pay the fee?

Each establishment that must register pays it. If you are not sure whether your establishment must register, ask us before paying.

Can we get a refund if we do not register?

FDA has a refund process for fees paid in error, with deadlines. It is safest to confirm you need to register before paying.

How Regovant can help

Regovant LLC registers device establishments, lists devices and acts as U.S. Agent for $369 a year, plus $49 per device listing. FDA's own annual fee is paid separately, and we walk you through it. See the medical device service, all guides or prices.

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