Medical Device Establishment Registration & Listing
Who Must Register for FDA Medical Device Establishment Registration?
Registration is required under 21 CFR Part 807 for any U.S. or foreign establishment involved in manufacturing, preparing, propagating, compounding, or processing medical devices for commercial distribution in the United States.
- Domestic device manufacturers, contract manufacturers, and processors
- Foreign device manufacturers, and exporters exporting to the U.S.
- Initial importers of foreign devices into the U.S.
- Establishments that repackage or re-label devices
- Specification developers who design devices for contract manufacture
- Remanufacturers who significantly change a finished device
- Licensed practitioners (physicians, dentists) who manufacture devices solely for use in their own practice
- Establishments that manufacture devices intended solely for veterinary use
- Manufacturers of components or parts intended solely for further manufacturing use by another registered establishment
- Distributors who only store finished devices and do not manufacture or repackage
Device Registration & Listing Services
LMG handles complete device establishment registration, device listing, and annual renewal for domestic and foreign medical device companies.
Establishment Registration
Full FDA establishment registration for device manufacturers, importers, and distributors — includes initial registration and annual renewal management.
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Device Listing
Registration of all medical devices you market in the U.S. — required for each device type with its applicable product code and classification.
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U.S. FDA Agent
Foreign device establishments must designate a U.S. Agent. LMG serves as your official FDA contact for all device regulatory communications.
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Annual Renewal
Device establishment registrations must be renewed annually October 1–December 31. We track and manage your renewal and MDUFA fee payment.
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MDUFA Fee Guidance
FDA charges an annual Medical Device User Fee (MDUFA) for device establishment registration. LMG guides you through the fee payment process.
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Device Label Review
Comprehensive medical device label review services to ensure compliance with FDA labeling requirements and mandatory labeling elements and regulatory standards.
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Frequently Asked Questions
Who must register as a medical device establishment?
Manufacturers, importers, and distributors of medical devices marketed in the U.S. must register with FDA — including foreign establishments that export devices to the U.S.
What is the MDUFA fee?
The Medical Device User Fee Act (MDUFA) requires FDA to charge an annual establishment registration fee. For FY2026, the fee is $11,423. This is a government fee paid directly to FDA.
Do I need to list every device I make?
Yes. Every device type must be listed separately with its applicable FDA product code. Each listing identifies the device, its intended use, and the applicable regulation.
When must registration be renewed?
Device establishment registrations must be renewed annually between October 1 and December 31 — along with payment of the annual MDUFA registration fee.
Ready to Register Your Device Establishment?
LMG handles FDA device establishment registration and listing for companies in 150+ countries.
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