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December 2, 2024
Approximately 5 minutes
US FDA Establishment Registration and Device Listing (FURLS) Requirements
US FDA Establishment Registration and Device Listing (FURLS)
Any establishment involved in the production, importation, reprocessing/relabeling, or developing specifications of a medical device or In Vitro Diagnostic (IVD) product for commercial sale in the United States must register annually with the U.S. Food and Drug Administration (FDA).
1. Establishment Registration
Establishment Registration is a mandatory, yearly process that is separate from obtaining a pre-market submission clearance (like 510(k) or PMA approval).
Who Must Register? As a general rule, any facility that manufactures all or part of a medical device sold in the U.S., or performs processing activities such as sterilization, must register.
The registration is completed through the FDA’s online Facility Establishment Registration and Device Listing (FURLS) system. A critical step is the payment of appropriate annual fees, which must be completed before the registration process can proceed.
2. Device Listing
In addition to registering the establishment, the FDA requires registered facilities to list the specific devices they manufacture or process. This listing is done using the Device Registration and Listing Module (DRLM) within the FURLS system.
Initial Importer Exemption An important exception exists for the Initial Importer. An Initial Importer is responsible for furthering the marketing of a foreign-manufactured device entering the U.S. to the final distributor. While Initial Importers must register their establishment, they are not required to list the devices they import.
When registering and listing, facilities must accurately identify the device Product Code and classification, which for new products often requires an initial assessment or relies on information provided in the 510(k) clearance letter.
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