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FDA – Medical Devices

Establishment Registration + US Agent

Fee: $599 / year

Establishments that manufacture, assemble or process medical devices for use in the United States register with FDA and list their devices. The registration is renewed each year between October 1 and December 31. FDA charges a separate annual fee for this registration ($13,785 for fiscal year 2027); this fee is not included in our consulting fee.

Who Is Obligated?

Domestic and foreign device manufacturers, as well as establishments such as initial importers, repackagers and sterilizers. A foreign establishment designates a single US Agent who resides or maintains a place of business in the United States.

What We Do

  • We assess your establishment’s registration obligation and the class of your devices.
  • We file the registration in FDA’s system on your behalf.
  • We serve as your designated US Agent.
  • We track the annual renewal and information verification period.

What You Receive

  • FDA establishment registration details
  • Summary of the information used in the registration
  • Renewal period reminder
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FDA Medical Device Establishment Registration and US Agent Application

Establishment, activity, official correspondent and importer details for the FDA registration of your medical device establishment (initial registration or annual renewal).

  1. 1 Preliminary Information
  2. 2 Facility
  3. 3 Activities
  4. 4 Official Contact and Billing
  5. 5 Submit
1. Preliminary Information
Where is the facility located? *
Requested action *
Has this year's FDA registration fee been paid? *
Have you applied for the FDA small business fee reduction? *

Your details are used only to prepare your application. An unfinished application is kept in this tab.

Frequently Asked Questions

Is FDA’s annual registration fee included in the consulting fee?
No. FDA charges a separate annual fee for device establishment registration; this fee is not included in our fee and is shown separately in the quote.
What does my fee cover, and when is it renewed?
Our fee is for the US Agent service and is renewed annually; in this package we are designated as your US Agent. Device establishment registration is also renewed each year between October 1 and December 31; we handle the renewal and information verification as part of our US Agent service.
I am an importer, not a manufacturer. Do I need to register?
Besides manufacturers, establishments such as initial importers, repackagers and sterilizers also register. We assess the obligation based on your activities.

Sources: 21 CFR 807.20; 21 CFR 807.22; 21 CFR 807.40; FDA: MDUFA user fees.