Medical Device Registration for Foreign Manufacturers: FY2027 Fees and Pathways

A foreign medical-device company should identify each establishment’s actual activity and each device’s FDA product code before choosing a service. Registration, listing and a US Agent can be required for a site even where a product is exempt from 510(k); conversely, these administrative steps do not clear or approve the device. Government fees and FDABridge’s professional quote are separate. https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee

Classify the device before choosing a premarket pathway

FDA product classification depends on intended use, the classification regulation and the product code. Most class I and some class II types are 510(k)-exempt, subject to exemption limits; many other class II types use 510(k), while certain high-risk devices require PMA. Do not infer the route from a broad product label or class alone. Check the specific FDA product classification record and exemption limits. https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-and-class-ii-device-exemptions

Match registration, listing and US Agent duties to the site

FDA’s activity table distinguishes foreign manufacturers, contract manufacturers, contract sterilizers, exporters, relabelers, specification developers and other roles. Many such sites register, list and pay the establishment fee; a component-only supplier or investigational-device site can have different treatment. A foreign establishment required to register normally designates a US Agent. Annual registration and listing review is October 1–December 31; initial registration and fee payment have separate timing, including before a foreign site exports. https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee https://www.fda.gov/medical-devices/device-registration-and-listing/when-register-and-list

Listing is not FDA clearance or approval

A device listing identifies the device and applicable product code and activity for a registering establishment. A needed 510(k) clearance, De Novo authorization or PMA approval is a separate product decision. FDA says registration and listing entries do not denote agency clearance, approval or authorization of the facility or device. A missing listing or expired registration may prevent lawful marketing, but completing them does not guarantee import admission. https://www.fda.gov/medical-devices/consumers-medical-devices/are-there-fda-registered-or-fda-certified-medical-devices-how-do-i-know-what-fda-approved

510(k), De Novo and PMA after a pathway review

FDA uses a 510(k) submission to compare a device with an existing legally marketed device. A positive substantial-equivalence decision is called 510(k) clearance. It is not PMA approval. A finding of not substantially equivalent (NSE) does not automatically require a PMA. An eligible novel class I or II device may use De Novo after an NSE finding, or directly when no suitable comparison device exists. Other devices may need PMA or another route. FDA may decline a De Novo request. Assess intended use, classification and evidence before choosing a route. See 21 CFR 860. 200. https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-860/subpart-D/section-860.200

FY2027 FDA government fees and small-business conditions

For FY2027 (October 1, 2026–September 30, 2027), FDA lists a $13,785 annual establishment registration fee for most fee-liable sites. Separate standard submission fees include $28,653 for a 510(k), $191,020 for a De Novo request and $636,732 for a PMA; they apply only when that submission is required. FDA-approved small-business determinations may reduce eligible submission fees, but there is no ordinary reduced annual registration fee. FDA may waive the annual fee, excluding initial registration, only after an approved determination for a business with no more than $1 million in gross receipts or sales including affiliates, proof of a prior registration-fee payment, and financial hardship accepted by FDA. For actively registered firms seeking the FY2027 waiver, FDA says supporting information is due by November 1, 2026. These are government fees, not FDABridge prices. Confirm current FDA rates and the actual role before payment. https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa-fees https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/reduced-or-waived-medical-device-user-fees-small-business-determination-sbd-program

Scope FDABridge’s existing services first

FDABridge helps clients with FDA device establishment registration, device listing and US Agent coordination. Ask for a professional service price quote. The work depends on the facility role and device records. Classification and any premarket submission need separate assessment. This guide does not offer preparation of De Novo or PMA submissions. It does not promise FDA clearance, approval or import admission. Request a price quote before work begins. Pay applicable FDA government fees separately. https://fdabridge.com/medical-devices https://fdabridge.com/contact?service=medical-devices