We support medical device and IVD manufacturers with FDA establishment registration, device listing, the US agent and UDI data in GUDID. A device made in an establishment that is not duly registered, or not listed, is deemed misbranded under section 502(o) of the FD&C Act.
Overview
Establishment registration, device listing, US agent and UDI for medical devices and IVD · 21 CFR Part 807 Subparts A to D · 21 CFR 801.20 · 21 CFR Part 830 · FD&C Act Sec. 510 and 502(o) · FDA guidance on GUDID
Last updated: November 1, 2026
Registration, listing and GUDID are three records in three FDA systems, each with its own deadlines. They have to describe the same device, the same establishments and the same premarket submission number, and the US agent has to be reachable for all of them. A gap in any one of them stops shipments.
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Mapping your establishments and roles against 21 CFR 807.20: manufacturer, specification developer, contract manufacturer and contract sterilizer, repackager and relabeler, initial importer, and the exemptions under 807.65. Deliverable: a register of establishments with owner or operator, official correspondent, activities per device and the listings each one carries.
Preparing the FURLS entries with the information required by 21 CFR 807.25: establishment, owner or operator, official correspondent, trade names, and for each device the product code or premarket submission number and the activities at each establishment. Before entry, we check that the registration fee has been paid and that the 510(k), De Novo or PMA number exists.
Selecting and onboarding the US agent: residence or place of business in the United States, reachability during business hours, a decision on whether the agent also acts as official correspondent, and a written scope that covers communication, product questions and inspection scheduling under 21 CFR 807.40(b)(2). The agent's change notices within 10 business days go into the same procedure.
Determining the labeler under 21 CFR 830.3, choosing an FDA-accredited issuing agency, and assigning device identifiers for each version or model and each device package (830.40, 830.50). On the label, the UDI appears in plain text and in AIDC form (801.40); for reusable devices that are reprocessed, we check whether direct marking under 801.45 applies, and for stand-alone software the display under 801.50.
Setting up the GUDID account with organization and labeler DUNS numbers, the data elements of 21 CFR 830.310 and their match with label, listing and premarket submission. Per the GUDID guidance, records for a new version or model should be published no later than 15 calendar days after it enters commercial distribution; we plan publication so that the grace period is used for checking.
A calendar for the annual registration and listing review between October 1 and December 31 (21 CFR 807.22(b)), registration changes within 30 days, listing changes when a device is introduced, changed or discontinued (807.28), the importers named under 807.41 and GUDID updates under 830.330(b).
How we work together
Establishment registration tells the FDA where devices for the US market are made and who is responsible for them. Device listing tells it which devices each establishment handles and what it does to them. Both run through the FDA's electronic registration and listing system (FURLS) and follow the FDA fiscal year, which starts on October 1 (21 CFR 807.3(u)).
For a manufacturer outside the United States, two further obligations come with registration. It designates exactly one US agent, who assists the FDA in communicating with the establishment and in scheduling inspections, and it names its importers and the persons who import or offer its devices for import (21 CFR 807.40, 807.41). Without registration and listing, no device from a foreign establishment may be imported, except for investigational use under Part 812 (807.40(c)).
The third record is the UDI. The label and the device package carry it, and the labeler submits the device identifier with its attributes to GUDID (21 CFR 801.20, 830.300). What the three records have to hold, and when:
| Registration | Listing | GUDID | US agent | |
|---|---|---|---|---|
| Who | owner or operator of each establishment | owner or operator, per device and establishment | labeler | foreign establishment |
| What | establishment, owner or operator, official correspondent, trade names | product code or premarket submission number, brand names, activities | device identifier and the attributes in 21 CFR 830.310 | name, address and phone number of one agent |
| When first | within 30 days of starting an activity | with the registration, for imports before the device enters | no later than the date the label must bear the UDI | with the initial registration |
| When again | every year from October 1 to December 31, changes within 30 days | yearly review, plus at introduction, change or discontinuation | at each change, no later than the first labeling with the changed information; information not on the label, such as the listing number, within 10 business days of the change (830.330(b)) | within 10 business days of a change |
| Basis | 21 CFR 807.22, 807.25(b) | 807.22(b), 807.25(g), 807.28 | 830.310, 830.330 | 807.40(b) |
Outside this page lie the choice between 510(k), De Novo and PMA on the page FDA Strategy & Pathways and the three routes themselves on the pages 510(k) Premarket Notification, De Novo Classification and Premarket Approval (PMA). The FDA inspection is covered on the page FDA Inspection Readiness & QMSR, and UDI under the MDR on the page Technical Documentation & UDI.
Our approach
Step
Result
Map roles and establishments
A register of establishments, roles and devices that shows who registers, who lists and who is exempt.
Set up the US agent
A designated US agent who has confirmed the role and is reachable, with a defined scope.
Register and list
Active registrations after payment of the fee and listings that carry the premarket submission numbers.
Label and submit UDI
Device identifiers on label and package and published GUDID records that match listing and premarket submission.
Keep records current
Annual registration and listing review completed within October 1 to December 31, and changes reported within their deadlines.
Common pitfalls
A registration certificate is used in sales material.
FDA states that it issues no registration certificates for device facilities, and 21 CFR 807.39 treats any representation that creates an impression of official approval because of registration or a registration number as misbranding. A registration number on a slide is not a clearance.
The listing is entered before clearance or approval.
For devices that need a 510(k) or PMA, FDA's registration pages state that registration and listing wait until the premarket submission is cleared or approved, and the listing then carries its number (21 CFR 807.25(g)(4)).
A design change keeps the old device identifier.
A change that results in a new version or model needs a new device identifier, as does a new device package (21 CFR 830.50); a relabeler assigns its own and keeps the link to the prior one (830.60).
The US agent is expected to handle reporting.
According to FDA's page on US agents, the agent has no responsibility for medical device reporting under 21 CFR Part 803 or for submitting a 510(k). These duties stay with the manufacturer and need their own owner.
Importers are left out.
Each foreign establishment names every importer known to it and every person who imports or offers for import its devices, on initial registration, annually and at each change (21 CFR 807.41(a) and (b)).
Regulatory Affairs
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
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Projects from this industry
Latest insights
All insights →FDA Strategy & Pathways →
Choosing between 510(k), De Novo and PMA before registration and listing
510(k) Premarket Notification →
The clearance whose number the listing carries
De Novo Classification →
The grant order whose number the listing carries
Premarket Approval (PMA) →
The approval whose number the listing carries
FDA Inspection Readiness & QMSR →
The inspection the US agent helps to schedule
Technical Documentation & UDI →
UDI under the MDR and EUDAMED, the European counterpart to GUDID
Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.
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