Standardized service

FDA Medical Device Establishment Registration

Manufacturers, initial importers, specification developers, and other establishments that intend to market medical devices in the U.S. must complete annual establishment registration with the FDA under 21 CFR Part 807 and pay the annual registration fee. We support classification checks, filing, and annual renewal.

RegulatorU.S. FDA

PrerequisiteU.S. Agent for foreign establishments

TimelineAbout 1-2 weeks

RenewalAnnual, October 1 to December 31

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What this service is

Establishment Registration is the FDA's annual registration requirement for device-related establishments under 21 CFR Part 807. It covers manufacturers, contract manufacturers, sterilizers, initial importers, repackers/relabelers, specification developers, foreign exporters, and similar entities.

Registration is filed online through the Device Registration and Listing Module (DRLM) of the FDA Unified Registration and Listing System (FURLS). The annual registration fee for the current fiscal year (October 1 to September 30) must be paid first, producing a Payment Identification Number (PIN) and Payment Confirmation Number (PCN). After registration, the FDA assigns the establishment a Facility Establishment Identifier (FEI).

FD&C Act §51021 CFR Part 807 Subpart BMDUFA

Who needs it

Foreign manufacturers and exporters planning to sell medical devices in the U.S.

Contract manufacturers, sterilizers, repackers, or relabelers serving the U.S. market

Specification developers marketing devices under their own brand in the U.S.

Initial importers bringing devices into the U.S. for the first time

Prerequisites and sequence

Designate a U.S. Agent→FDA Establishment Registration

Device classification, product code, and regulation number are determined, and the 510(k) status is known (exempt, cleared, or submission required).
Foreign establishments must designate a U.S. Agent first; U.S. Agent details are required during registration.
Establishment details (Chinese and English names, addresses, official correspondent) must match the company's actual records for FDA verification.
The annual registration fee is paid directly to the FDA (wire transfer or credit card); the PIN/PCN must be obtained before the registration can be submitted.

Who holds regulatory responsibility

The registering party is the establishment's owner/operator. We help confirm classification and product codes, prepare the registration, and track payment and submission; the establishment is responsible for the accuracy of the filing and must designate an Official Correspondent to maintain the account.

Materials we need from you

Company name in Chinese and English, registered address, and production site address

Official correspondent name, title, phone, and email

Device list with product codes and regulation numbers (if already determined)

510(k) numbers for cleared devices (if applicable)

U.S. Agent information (foreign establishments)

Process

01
Confirm device classification, product codes, and 510(k) status
02
Confirm or arrange the U.S. Agent designation
03
Guide payment of the FDA annual registration fee and obtain the PIN/PCN
04
Set up the account in FURLS/DRLM and submit the establishment registration
05
Obtain the registration confirmation and FEI, then verify the recorded information
06
Connect to the follow-on device listing step

Deliverables

FDA establishment registration confirmation

FEI and a verification record of the registered information

Annual renewal window reminder (October 1 to December 31 each year)

Timeline

With complete information and confirmed classification, registration typically takes about 1-2 weeks; classification work or payment verification extends the timeline accordingly.

Scope

What we provide

Device classification and product code verification
Registration preparation and online submission
Payment process guidance (PIN/PCN)
Post-registration verification and record archiving
Coordination with device listing and U.S. Agent services

What is not included

The FDA annual registration fee itself (paid by you directly to the FDA; the amount is set per fiscal year)
Premarket submissions such as 510(k) (separate engagement)
FDA inspection accompaniment and remediation support (assessed separately)

What usually follows

Device Listing Device Label Review FDA 510(k) Submission

Common pitfalls

Treating establishment registration as marketing authorizationRegistration only registers the entity; it does not authorize sale. Each device must also be listed, and non-510(k)-exempt devices need clearance or another premarket authorization before marketing.

Missing the October-December annual renewal windowRegistration follows the FDA fiscal year: the new year's fee must be paid and information updated between October 1 and December 31. Missing the window can invalidate the registration and affect shipments.

Planning submission before the fee payment (PIN/PCN)The annual registration fee must be paid first to obtain the PIN/PCN, and wire transfers take time to clear. Leaving payment out of the project plan directly delays the registration submission.

Filing data that does not match company recordsMismatched establishment names, addresses, or official correspondent details can fail FDA verification. After a relocation or name change, update the underlying company records first, then the registration.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

Request a quote

FAQ

Does establishment registration need to be renewed every year?

Yes. Registration follows the FDA fiscal year. The annual renewal window runs from October 1 to December 31, during which the new fiscal year's fee must be paid and establishment and listing information updated. Missing the window can invalidate the registration.

Does registration mean the device can be sold in the U.S.?

No. Establishment registration only registers the entity. Each device must also be listed, and unless the device is 510(k)-exempt, it must first obtain 510(k) clearance or another premarket authorization before marketing.

Must foreign manufacturers appoint a U.S. Agent?

Yes. The FDA requires establishments located outside the U.S. to designate a U.S. Agent as the contact between the FDA and the establishment, handling routine communication and helping schedule facility inspections.

Can registration status be checked on the FDA website?

Yes. The FDA maintains a public registration and listing database where the establishment's registration status can be verified after completion.

Related services

Device U.S. AgentThe FDA requires foreign device establishments to designate an agent located in the United States as its routine point of contact. We serve as your U.S. Agent on an annual basis, handling FDA communication, registration maintenance, and inspection coordination.Device ListingAfter establishment registration, every device marketed in the U.S. must be listed with the FDA, declaring its product code, proprietary name, and premarket submission number. Listing is handled per device, and we complete each filing with you.510(k) SubmissionThe 510(k) is the premarket pathway for most Class II and some Class I devices: demonstrating to the FDA that your device is substantially equivalent to a legally marketed predicate. We support the full project from strategy to clearance.

Disclaimer

This is a registration assistance service, not legal advice. The FDA annual registration fee is set by the FDA per fiscal year; refer to the official amount in effect at the time of filing.