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FDA Medical Device Registration Form

Complete this form to register your medical device establishment with the FDA. LMG will review your details and contact you within 1 business day.

21 CFR Part 807 US Agent Included Fixed Price Since 2009

Description of Services & Cost

ServicesFeesNumber of ServicesTotal Fees
Establishment Registration & US AgentOwner/Operator Number, Registration Number, Official Correspondent (Annually) USD 449 $0
Device ListingPer additional device USD 50 $0
Label ReviewPer device USD 649 $0
FDA Registration Fee for 2026Paid directly to FDA — not included in LMG fees USD 11,423 Pay directly to FDA ——
Total (LMG Fees Only)$0
All LMG fees are in USD. Fixed price — no hourly fees or hidden charges. Work commences upon receipt of payment.
The FDA establishment registration fee of USD 11,423 (2026) is paid directly to the FDA separately and is not collected by LMG. Foreign establishments that export devices to the US are required to pay this fee annually.

Establishment Details

Provide the physical address of the manufacturing or processing establishment.

Required.
Required.
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A DUNS number is required for FDA registration. If not yet available, leave blank — LMG will guide you on obtaining it free of charge.

Establishment Contact

Required.
Required.
Required.
Required.
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Valid email required.
Required.

Type of Operation *

Please select at least one type of operation.

US Importer / Distributor (for foreign establishments only)

Manufacturer (for US establishments only)

Medical Device Information

Enter details for each medical device to be listed. The first device is required. Click "Add Another Device" to add more.

Submitter Information

Required.
Required.
Valid email required.

Agreement

Terms and Conditions — Medical Device Registration
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We appreciate your decision to select Liberty Management Group Ltd. ("LMG") to register your medical device establishment with the United States Food and Drug Administration ("FDA") as required by 21 CFR Part 807. This Agreement describes the scope of our relationship with your company. By submitting the requested registration information to LMG, your company agrees to be bound by the terms and conditions listed in this document.

1. Services Provided

Our services will be limited to providing the FDA with information necessary to properly and timely register your establishment with the FDA to comply with the Act. The services will include assisting your company to obtain an Owner/Operator Number and Registration Number. On the registration form required by the FDA, "Liberty Management Group Ltd." will be identified as the "U.S. Agent" and "Official Correspondent" for your company. You understand and agree that the information your company provides to LMG for the purpose of completing and submitting the FDA registration under the Act will not be privileged or confidential information, and will be used for the purpose of completing a public filing with, among other entities, the United States Government. As "U.S. Agent", LMG may receive notices from the FDA on your behalf relating to the filing, and will transmit such notices to you.

2. Client Information

You agree and warrant that all information your company provides to LMG, including but not limited to any information necessary to register your company under the Act (collectively, "Client Information"), is correct and truthful to the best of your knowledge. You understand and acknowledge that LMG will rely upon the Client Information your company provides. You further agree and warrant that you will promptly inform LMG of any changes in the Client Information on the registration form that are required to be updated with the FDA within thirty (30) days of the change.

3. Termination Notices

Either party may terminate the relationship at any time for any reason by providing five (5) days' prior written notice to the other party. In the event of termination of this Agreement by either party, LMG shall not be liable to your company for any reimbursement or damages on account of the loss of prospective or actual sales or profits of your company, or for your company's expenditures, inventory, investments, leases, or commitments connected with the business or goodwill of your company. In no event shall LMG's liability exceed the amount of the fees paid by your company to LMG in any given calendar year.

4. Limitations

LMG shall not be liable for any delay in performing its obligations under this Agreement if such delay is caused by circumstances beyond LMG's reasonable control.

5. Governing Law and Venue

This Agreement and the interpretation of its terms shall be governed and construed in accordance with the laws of the State of Illinois, U.S.A., without regard to its conflicts of laws rules. The parties consent to the sole and exclusive jurisdiction and venue of the Illinois courts in Will County, Illinois, U.S.A.

After submission, LMG will review your application and contact you within 1 business day.

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