FDA Establishment Registration and Listing || Tacit MedTek

Medical Device Services

Quick Snapshot

Who can apply –
- Medical device manufacturers
- IVD manufacturers
- Foreign Manufacturers exporting to the U.S.
- Contract manufacturers
- Re-packagers and Relabels
- Specification developers
Timeline – Registration and Device Listing can generally be completed once the required company and product information is available. Timelines may vary depending on the completeness of documentation and regulatory requirements.
Fee – FDA Establishment Registration fees are updated annually by the FDA. Current fees can be verified directly through the FDA website.

What is FDA Establishment Registration and Listing?

FDA Establishment Registration and Device Listing are mandatory requirements for companies involved in manufacturing, processing, sterilizing, repackaging, relabelling, importing, or distributing medical devices in the United States.

Establishment Registration identifies the company or facility with the FDA, while Device Listing provides information about the medical devices being marketed in the U.S.

Although registration and listing do not represent FDA approval or clearance, they are essential compliance requirements for legally marketing medical devices in the United States.

When Do You Need FDA Registration Support?

Support for FDA establishment registration, device listing, U.S. Agent requirements, product-code selection, and annual compliance updates.

When Do You Need FDA Registration Support?

Manufacturing or exporting medical devices to the U.S.
Launching a new medical device in the U.S.
Foreign manufacturers supplying U.S. customers
Establishing new manufacturing or sterilization facilities
Updating ownership, facility, or device listing information with FDA
Renewing annual FDA establishment registration and device listing

Key Challenges

Incorrect establishment registration details
Improper device listing and product code selection
Difficulty identifying FDA device classification
U.S. Agent compliance issues for foreign manufacturers
Annual registration renewal errors
Non-compliance with FDA electronic submission requirements
Delays caused by inaccurate documentation
Understanding FDA database and listing requirements

Our Approach and What You Will Get

Structured support for FDA establishment registration, device listing, U.S. Agent coordination, renewals, and ongoing compliance.

Our Approach

Review business activities and FDA establishment type
Prepare FDA Establishment Registration
Prepare and submit Device Listing information
Coordinate U.S. Agent requirements for foreign manufacturers
Support annual renewals and listing updates

What You Will Get (Deliverables)

FDA Establishment Registration support
FDA Device Listing support
Product code and classification assessment
U.S. Agent coordination support
Labelling and IFU compliance review
Annual renewal support
Regulatory compliance guidance for FDA registration requirements

Why Choose Tacit Medtek and Case Example

Practical FDA registration and device-listing support for medical device and IVD manufacturers entering or maintaining access to the U.S. market.

Why Choose Tacit Medtek

Understanding of FDA registration and listing requirements
Support for domestic and international manufacturers
Experience with medical devices and IVDs
Assistance with device classification and product code identification
Support for U.S. Agent coordination
Practical guidance on annual renewals and updates
End-to-end regulatory support

Case Example

Challenge: A contract manufacturer producing orthopedic devices for multiple international brands needed FDA Establishment Registration and Device Listing support but faced challenges identifying the correct establishment type and managing multiple device listings accurately.
Our Approach: Evaluated the manufacturer’s operational activities and FDA establishment category; identified applicable regulation numbers and product codes for each device; assisted with FDA Establishment Registration and multiple Device Listings; reviewed device labelling and manufacturing information for compliance; and supported electronic submission and FDA database coordination.
Outcome: FDA Establishment Registration and Device Listing were completed successfully, enabling faster market access for U.S. distribution partners, improving compliance readiness for future FDA inspections and updates, and establishing long-term regulatory support for ongoing compliance management.

FAQ

Frequently Asked Questions

Is FDA registration the same as FDA approval?

No. Registration only identifies the establishment with FDA, while approval or clearance (such as 510(k)) authorizes a device to be legally marketed.

Is device listing mandatory for all medical devices?

Yes, all medical devices marketed in the U.S. must be listed under the registered establishment, unless specifically exempted by FDA regulations.

How often must FDA registration be renewed?

FDA establishment registration must be renewed annually between October 1 and December 31 of each year.

What is the difference between registration and listing?

Registration identifies the business entity, while listing identifies the specific devices being manufactured or marketed by that entity.

Do importers need to register with FDA?

Yes, initial importers of medical devices must register their establishments and list the devices they distribute in the U.S.

What is a Device Establishment Identifier (FEI)?

FEI is a unique number assigned by FDA to identify registered establishments and track regulatory activities.

Does FDA registration mean my device is FDA approved?

No. Registration identifies the establishment with FDA and does not indicate FDA approval, clearance, or certification.

What is a U.S. Agent?

A U.S. Agent acts as the communication link between FDA and foreign manufacturers.

When should Device Listing be updated?

Device Listings should be updated whenever there are significant changes to listed devices or company information.

Do I need to renew FDA registration every year?

Yes. FDA Establishment Registration must be renewed annually during the FDA registration renewal period.

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