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Selling or importing medical devices into the U.S. requires annual FDA establishment registration and device listing through FURLS (FDA Unified Registration and Listing Systems). The requirements differ by establishment type, and errors or missed renewals affect your market access. Since 2007, QSS has helped domestic and foreign establishments get registered, listed, and current.
FDA establishment registration and device listing through FURLS (the FDA's centralized registration and listing portal) are foundational to lawful U.S. distribution. Without a valid registration, FDA can refuse entry of your devices at the U.S. border. For foreign medical device establishments entering the U.S. market, your FDA registration number must be on file with your U.S. importer and kept current.
Annual registration runs October 1 through December 31. Device listing must also be updated whenever a device is introduced, discontinued, or materially changed. Your registration status is publicly visible in the FDA's database; distributors and retail partners check it, and keeping it current protects both your regulatory standing and your commercial relationships.
Not every type of establishment registers the same way, and some are exempt entirely. QSS reviews your establishment’s activities (manufacturing, contract manufacturing, repackaging, relabeling, or initial importing) to confirm your registration obligations under 21 CFR Part 807. We identify the correct owner/operator designation, clarify which activities trigger registration, and flag any exemptions that may apply before you begin.
The FDA Unified Registration and Listing System (FURLS) requires each owner or operator to hold a valid login with appropriate account credentials. For establishments with an official correspondent or authorized agent, sub-account configuration is also required. QSS guides you through account creation, access configuration, and official correspondent designation so your portal setup is correct from the start.
Device listing is a parallel obligation to establishment registration, and it must be kept current. QSS prepares your device listings using accurate product classification, FDA product codes, and device identifiers, and submits them through the FDA Device Registration and Listing Module (DRLM) within FURLS. We also review existing listings for completeness and flag any updates required based on product changes or discontinuations.
Initial importer medical device registration carries distinct requirements from those applicable to manufacturers or repackagers. As the entity that first brings a foreign device into U.S. commerce, initial importers must register independently and maintain their own listing obligations. QSS advises initial importers on their specific registration scope, ensures the correct establishment type is selected in FURLS, and prepares all required submissions accurately.
FDA establishment registration must be renewed annually during the October 1 to December 31 renewal window. QSS tracks your renewal obligations, prepares updated submissions, and confirms your registration is active before the window closes. For multi-establishment clients or companies managing registrations across several device lines, we coordinate the full renewal cycle to ensure nothing is missed.
Foreign establishments registering with the FDA are required to designate a U.S. Agent who resides or maintains a place of business in the United States. QSS advises on U.S. Agent obligations, helps identify and formalize this designation within FURLS, and ensures your foreign establishment registration reflects the correct contact information for FDA communications.
If your registration has lapsed, contains errors, or was submitted under the wrong establishment type, QSS conducts a targeted remediation review. We identify what needs to be corrected, prepare the updated submissions, and document the corrective steps taken. For companies facing an upcoming audit, inspection, or import issue, we prioritize accuracy and completeness to support your broader compliance position.
Domestic and foreign establishments that manufacture, prepare, assemble, or process medical devices intended for U.S. commercial distribution are required to register annually with the FDA. This includes manufacturers, contract manufacturers, repackagers, relabelers, and initial importers. Some establishment types are exempt; for example, manufacturers whose devices are already cleared, approved, or otherwise exempt under 21 CFR Part 807, or establishments that solely perform certain service functions. Confirming whether your specific activities trigger registration is an important first step before submitting through the FURLS online portal.
FURLS stands for FDA Unified Registration and Listing System. It is the FDA’s centralized electronic portal for establishment registration and device listing submissions across multiple regulated product categories, including medical devices. Through FURLS, owners or operators create and manage their registration accounts, submit device listings, designate official correspondents, and complete annual renewals. All medical device establishment registration and listing activity is now conducted through the Device Registration and Listing Module (DRLM) within FURLS. Access requires a valid FDA account with appropriate owner or operator credentials.
Device listing is the process by which establishments identify the devices they handle in U.S. commerce and associate those devices with their registered establishment. FDA medical device listing requirements include providing the device’s FDA product code, the proprietary and established name, the type of submission (510(k), PMA, De Novo, or exempt), and any relevant device identifier information. Listings must be updated when a new device is introduced, when a device is discontinued, or when certain information about the device changes materially. Listing and registration are related but separate obligations; both must be current for your establishment to be in good standing.
Yes. FDA establishment registration must be renewed annually. The renewal window runs from October 1 through December 31 each year. Registration that is not renewed within this window becomes inactive. An inactive registration can affect your standing with U.S. distributors and importers, and can create complications at the border for foreign establishments. QSS tracks renewal windows for clients and prepares submissions in advance of the December 31 deadline to ensure continuity.
The FDA collects an annual establishment registration fee for most medical device establishments. The fee amount is set by the FDA each fiscal year and applies to both domestic and foreign establishments, with some exceptions. Certain small businesses and establishments meeting specific criteria may qualify for a reduced fee or exemption. QSS confirms applicable fee status as part of the registration process and ensures the correct payment is submitted alongside your registration to avoid processing delays.
Foreign establishments have a few requirements that differ from their domestic counterparts. First, a foreign establishment must designate a U.S. Agent — an individual or business physically located in the United States who can serve as the FDA’s point of contact for the establishment. Second, the foreign establishment’s registration number must be provided to any U.S. initial importer bringing their devices into commerce. Third, foreign establishments must ensure their registration reflects accurate contact information and that the U.S. Agent designation is maintained and current. QSS works with foreign establishments on each of these requirements as part of a complete registration engagement.
An inactive or inaccurate registration can have practical consequences for your U.S. distribution. Devices imported by an initial importer that cannot provide a valid foreign establishment registration number may be refused entry at the U.S. border. Domestically, an inactive registration may affect your ability to lawfully distribute and could be flagged during an FDA inspection. If your registration has lapsed or was submitted with incorrect information, QSS can conduct a remediation review to identify the gaps, prepare corrected submissions, and document the steps taken to restore compliance.