FDA Compliance Solutions for Medical Devices
The B2B TradeCenter provides complete FDA compliance support for companies in the medical device sector that want to legally market their products in the U.S. Our team includes technical and regulatory compliance specialists as well as former FDA employees, ensuring that every step of the process is fully compliant.
FDA Registration
U.S. Agent Services
Product Review
Product Compliance
FDA Registration made Simple
FDA medical device establishment registration can be a complex process, but we make it simple and stress-free. Our team of experts will guide you through each step to ensure your facility is properly registered with the FDA.
Here’s how our process works:
1
Fill out our comprehensive intake form. Submit your company details, and our team will assist you with completing the form and providing the necessary documentation.
2
We submit your data and ensure compliance for:
Class I (no 510(k) required)
Class II (after 510(k) clearance)
Class III (after PMA approval)
3
Receive the official proof of registration and FDA registration certificate. Unlike many competitors, we provide you with all account and registration details, including the FDA’s official proof of registration.
Get registered now!U.S. Agent Services for FDA Communication
Foreign manufacturers must designate a U.S. Agent with the FDA. We act as your direct contact, providing support that goes beyond basic representation.
Speak with a U.S. Agent
Facility identifier reports (UFI, FEI)
Registration updates and renewals
Assistance with FDA communications and regulatory responses
510(k) Submission for Class II Devices
The FDA requires Class II devices to undergo the 510(k) process to demonstrate substantial equivalence to a previously approved device in the U.S.
Guidance on required documentation
Support with performance and safety testing
Submission of the 510(k) dossier and follow-up with the FDA
Status tracking and support throughout the process
⚠️ We do not handle new PMA submissions (Class III), but we assist with facility registration once PMA approval is obtained.
Find out more about 510(k)
Medical Device Product Listing
Once your establishment is registered, all devices must be officially listed with the FDA.
Our service includes:
Individual listing for each device
Submission of new listings for additional products
Mandatory annual listing updates
Review of Medical Device Labels
Proper labeling is mandatory for legal entry into the U.S. market. Avoid errors and detentions with our specialized label review service.
Verification of required elements (e.g., warnings, instructions for use)
Assessment of compliance with regulatory requirements, including UDI and GUDID reporting requirements.
Detailed report with practical recommendations
Still have questions about our services?
Read the most common questions from
B2B TradeCenter
clients
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What is the FDA?
The FDA (Food & Drug Administration) is the U.S. federal agency responsible for regulating medical devices, drugs, food, and other products to ensure their safety and effectiveness for use in the United States.
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Does my medical device need FDA approval?
It depends on your device classification. Class I devices are generally exempt, Class II requires a 510(k), and Class III requires Premarket Approval (PMA).
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What is FDA Registration?
FDA registration involves registering your manufacturing or distribution facility with the FDA. This is required for all companies intending to sell medical devices in the U.S.
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Do I need a U.S. Agent?
Foreign manufacturers must appoint a U.S. Agent to act as their official contact for FDA compliance registration matters.
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Do you help with labeling?
Yes. We review your medical device labels to ensure they meet FDA requirements, including all necessary warnings and instructions for use.
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Can you issue UDIs for my devices?Can you issue UDIs for my devices?
Yes. We assist in generating and submitting Unique Device Identifiers (UDI) as required by FDA regulations. And, we also submit the product UDI data to the FDA’s GUDID, its reference catalog for every device with a UDI.
