U.S. FDA registration & U.S. Agent services · Casper, Wyoming, USA info@regovant.com+1 307-301-7465
Regovant LLCFDA Registration & U.S. Agent
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FDA Medical Device Establishment Registration & Listing

We register your device establishment with FDA, list your devices, and act as your U.S. Agent. Our fee is $369 a year. FDA's own annual fee is paid separately, and we tell you exactly how before we file.

  • Establishment registration with U.S. Agent service: $369 a year
  • Device listing: $49 per device
  • Help with FDA's fee payment, PIN and PCN
Ask a question

Medical device pricing

USD
Registration + U.S. AgentPer establishment, per year$369
Device listingPer device$49
GUDID account setupOne time$269
Device label reviewPer device$369
FDA annual fee, FY2027 (paid to FDA)$13,785

Who must register?

Under 21 CFR Part 807, establishments involved in making or distributing medical devices for the U.S. market must register with FDA every year and list the devices they handle. That includes:

  • Manufacturers and contract manufacturers
  • Specification developers
  • Contract sterilizers
  • Repackagers and relabelers
  • Foreign exporters and initial importers

Foreign establishments must also name a U.S. Agent. Registration is renewed every year between October 1 and December 31.

FDA's annual establishment fee

Before FDA accepts a device registration, the establishment must pay FDA's annual registration fee. For fiscal year 2027 (October 1, 2026 to September 30, 2027) it is $13,785. The fee is the same for small businesses. FDA can grant a waiver only in limited hardship cases.

You pay this fee directly to FDA. It is not part of our price. Once it's paid, FDA issues a payment PIN and PCN, which we use to complete your registration.

Registration is not clearance

Registering and listing tell FDA who you are and what you make. They do not clear or approve a device. Most Class II devices and some Class I devices need a 510(k) before they can be sold in the U.S., and Class III devices usually need premarket approval. We check your device's classification and product code when we list it, and quote separately for 510(k) work.

What's included

  • Check of your establishment type and device classification
  • Step-by-step help paying FDA's annual fee
  • Preparation and submission of the establishment registration
  • U.S. Agent service for one year for establishments outside the U.S.
  • Your registration and owner/operator numbers, plus a Regovant certificate of registration you can verify online
  • A reminder before the October–December renewal window

How it works

  1. Order online for the registration and each device to be listed.
  2. Send your details using our registration form: establishment type, devices, product codes and any 510(k) numbers.
  3. Pay FDA's fee. We send instructions, and you pay FDA directly.
  4. We register and list. You receive your registration number and confirmation.

Questions

Why is FDA's fee so much higher than yours?

FDA's annual registration fee funds its device review program and is set by law each year. Our fee covers the filing work and U.S. Agent service.

Do Class I devices need registration?

Yes. Most Class I devices are exempt from 510(k), but the establishment still has to register and list them.

Does a distributor need to register?

U.S. distributors that don't import, relabel or repackage usually don't. Initial importers and foreign exporters do. We'll confirm your role before filing.

When do I renew?

Every year between October 1 and December 31, including paying FDA's fee for the new fiscal year.