From Factory to FURLS: Step-by-Step FDA Registration and Listing for Device Manufacturers
Moving from a finished device on the factory floor to a compliant footprint in the FDA Unified Registration and Listing System (FURLS) requires orderly execution. For first-time filers, this is not just an administrative checkbox—it is your declaration to the federal government of who you are, where you operate, and what you introduce into U.S. commerce.
Step 1: The Data Foundation
Before you ever log into FURLS, you need clarity on your supply chain. You will need a DUNS number for each facility and a precise definition of the "role" each facility plays (e.g., Manufacturer vs. Contract Manufacturer vs. Specification Developer). Misidentifying these roles is a common error that can trigger unnecessary fees or confuse FDA investigators.
How BRS LLC Helps: We audit your facility list before registration begins, ensuring your DUNS data matches your corporate reality and that your site roles align with 21 CFR 807.
Step 2: Execution and Payment
Once the account is structured, the execution phase begins. This involves paying the annual User Fee (MDUFA) and creating the Establishment Registration. Immediately following registration, you must enter your Device Listings. This is where precision matters most: selecting the correct Product Code, Regulation Number, and Proprietary Names.
Errors here ripple outwards. A wrong product code can flag a shipment at U.S. Customs. A mismatch in proprietary names can cause issues with hospital purchasing systems or insurance reimbursement. Furthermore, your listing data sets the stage for your Unique Device Identifier (UDI) and Global Unique Device Identification Database (GUDID) obligations.
How BRS LLC Helps: We manage the entire submission workflow. We validate your product codes against your 510(k) or exempt status, and we align your listing data with your UDI/GUDID strategy to ensure consistency across databases.
Step 3: Governance and Maintenance
The most dangerous misconception is that FURLS is "set and forget." It is a living asset. Your registration must reflect your current reality at all times. If you move a warehouse, discontinue a product, or acquire a new facility, FURLS must be updated immediately.
This "single source of truth" approach minimizes surprises during inspections. When an FDA investigator shows up, they pull your registration data first. If their physical observation of your facility doesn't match your FURLS profile, the inspection starts on the wrong foot.
Your Compliance Execution Partner
BRS LLC provides end-to-end support for the device lifecycle:
- Registration & Listing: Accurate, validated initial setup and annual renewals.
- UDI & GUDID: Aligning your public FDA data with your labeling and barcoding strategy.
- Change Control: Managing site transfers, M&A updates, and listing deactivations.
- Official Correspondent: Serving as the reliable administrative interface for FDA accounts.
Don't let administrative errors slow down your market entry. Let us build a clean, defensible registration footprint for you.