Establishment registration
Review the facility's role, registration duty and FDA fee, then coordinate the applicable establishment filing.
Ask for a scoped quoteMedical device exports
FDA Registration for Medical Device Manufacturers
Medical device establishment registration, device listing, and US Agent services. Contact us for a custom quote.
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How medical device registrations are handled
- ✓ Scope reviewed before pricing is finalized
- ✓ Payment link sent after review
- ✓ Device class and establishment role checked before quoting
What’s involved
Medical Device Registration Overview
Check the work performed at each physical facility. Check the device's FDA product code. Some facilities must register with FDA, list devices, pay a government fee and name a US Agent. The requirements depend on facility activity. Device classification and premarket review are separate. FDABridge can quote a price to help you with registration, device listing and US Agent coordination after reviewing your scope.
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Check each site’s role against FDA’s register, list and pay table; a finished-device manufacturer, contract manufacturer, exporter, specification developer or component supplier can have different duties.
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Use the FDA product classification database to confirm the device class, product code and any limited 510(k) exemption before planning a submission.
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Registration and listing do not mean FDA clearance or approval. A 510(k) clearance, De Novo authorization or PMA approval is a separate product decision when applicable.
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A foreign establishment that must register normally names a US Agent. Annual registration and listing review runs October 1–December 31; initial timing and payment are separate.
Choose the device work you need
We review the activity at each establishment and the device product code before quoting. Registration and listing do not grant FDA product clearance or approval.
Device listing
Identify the device and product code, then scope the listing or update linked to the correct registered establishment.
Ask for a scoped quoteU.S. Agent coordination
For an eligible foreign establishment, confirm the appointment and agent consent before identifying the U.S. Agent to FDA.
Ask for a scoped quoteFY2027 FDA government fees are separate
For October 1, 2026–September 30, 2027, FDA lists a $13,785 annual device establishment registration fee for most fee-liable sites. It is paid to FDA, separately from FDABridge’s professional quote and from any applicable 510(k), De Novo or PMA submission fee. FDA-approved small-business status can reduce some submission fees; it does not automatically reduce the annual registration fee. A narrow hardship waiver for qualifying prior registrants excludes initial registration. Confirm the site’s role and current FDA assessment before paying.
Check FDA FY2027 device feesMedical Device FAQ
Questions device manufacturers ask before starting
Common questions from foreign medical device manufacturers before they begin US registration work.
Do foreign medical device manufacturers need FDA establishment registration?+
It depends on the facility's activity. Foreign manufacturers of finished devices and some other facility types generally must register with FDA, list devices and pay the FDA registration fee. Other facility roles have different requirements. Check FDA's activity table for each facility.
What is the difference between establishment registration and device listing?+
Registration identifies the establishment and its activity; listing identifies the device and product code. The role determines each duty. Neither registration nor listing is FDA product clearance or approval.
Do I need a US Agent for medical devices?+
A foreign device establishment required to register normally designates a US Agent as FDA’s contact. Confirm the role before assuming this applies to every supplier or component site.
When must I renew my device establishment registration?+
Annual device registration and listing review is due October 1–December 31. Initial registration and fee payment follow separate timing, including before a foreign site begins exporting. Renewal alone does not guarantee import admission.