FDA Medical Device
Registration & Compliance
Complete FDA registration, 510(k) clearance support, UDI submissions, and device listing services for domestic and foreign medical device manufacturers worldwide.
Medical Device Establishment Registration
All manufacturers, specification developers, repackers, relabelers, and initial importers of medical devices must register their establishments with the FDA under Section 510 of the FD&C Act. Registration is required before devices can be legally marketed in the United States and must be renewed annually between October 1 and December 31 with the applicable MDUFA user fee paid.
Additionally, device manufacturers must list all devices manufactured at their registered establishment. If the device is not 510(k) exempt, it needs to submit a 510(k) premarket notification for Class II devices, or obtain Premarket Approval (PMA) for Class III devices before commercialization. LMG supports all stages of this process.
Our Medical Device Services
End-to-end FDA regulatory support for Class I, II, and III medical device manufacturers and importers.
Establishment Registration
Initial FDA establishment registration for domestic and foreign device manufacturers, specification developers, repackers, and importers under 21 CFR Part 807.
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Registration Renewal
Annual renewal of medical device establishment registration with MDUFA user fee payment assistance. LMG ensures timely renewal to prevent lapse and import holds.
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510(k) Premarket Notification
Expert 510(k) preparation and submission for Class I and Class II medical devices seeking FDA market clearance. LMG has over 50 verified clearances on record.
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Device Label Review
Comprehensive review of medical device labeling for FDA compliance including required symbols, intended use statements, and UDI placement requirements.
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UDI Submission
Unique Device Identifier (UDI) submission to the Global Unique Device Identification Database (GUDID) — required for most medical devices sold in the U.S.
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Certificate to Foreign Government (CFG)
FDA-issued Certificate to Foreign Government confirming device clearance status — required by many international regulatory authorities for market access.
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CFG-NE Export Certificate
Certificate for exporting medical devices not currently marketed in the U.S. Required by importing countries to verify device status with FDA.
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U.S. FDA Agent
Mandatory for all foreign device establishments. LMG provides 24/7 U.S. Agent representation and direct FDA liaison services.
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FDA MDUFA Fees
LMG helps you understand applicable medical device registration fees and ensures timely payment to maintain active registration status.
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How the Process Works
Our streamlined process gets your establishment registered quickly and accurately.
Device Classification
We identify your device class (I, II, or III) and determine the correct regulatory pathway.
Documentation Prep
Preparation of all establishment registration forms, device listings, and required declarations.
FDA Submission
Submission through the FDA Unified Registration and Listing System.
Registration Confirmed
Registration confirmed, FEI number assigned, and your FDA certificate is issued.
Why Choose LMG
Trusted by businesses in 150+ countries for accurate, fast, and affordable FDA compliance.
Fast Turnaround
Most registrations completed within 1–3 business days. We understand that time-to-market matters.
Secure & Confidential
Your product formulations and business data are handled with strict confidentiality protocols.
150+ Countries Served
We have successfully registered establishments from over 150 countries in the FDA system.
Price-Lock Since 2009
LMG has never raised its fees. Transparent, fixed pricing with no hidden charges ever.
Dedicated Support
Direct access to your regulatory specialist throughout the entire registration process.
Verified Results
Our 510(k) clearances are verifiable in FDA database, and registration certificates are verifiable at our website.
Ready to Register Your Medical Devices with the FDA?
LMG has been helping businesses worldwide achieve and maintain FDA compliance since 2009. Our team is ready to guide you through every step of the process.