Your Website, Your Labeling, and Your Device Listing: Why FDA Cares if the Story Doesn’t Match
Marketing teams want to sell features. Regulatory teams need to defend indications. When these two narratives drift apart, you create a "misbranding gap"—and your public Device Listing is often the evidence FDA uses against you.
Every FDA Device Listing is tied to a specific Product Code (ProCode) and Regulation Number. These codes carry inherent definitions of what the device is and what it does. If your marketing materials or website claims begin to drift outside those definitions—promoting a "wellness" device for disease treatment, or a Class I exempt device for a high-risk indication—you are effectively marketing an unapproved device.
This misalignment is one of the most common triggers for Warning Letters. FDA's automated tools and reviewers routinely check manufacturer websites against their FURLS listings. If your website promises "AI-driven diagnostics" but your listing is for a generic "medical image management system," the discrepancy is obvious. The listing itself becomes proof that you have introduced a new intended use without a new 510(k).
The Proprietary Name Trap
Another frequent issue is the "Proprietary Name" field in FURLS. Manufacturers often list a device under an internal project code or an old brand name, while the website uses a flashy new commercial name. If a hospital or FDA investigator searches for your new brand and finds nothing in the database, they assume the device is unregistered. Keeping your proprietary names synchronized across labeling, web, and FURLS is a basic but critical compliance control.
How BRS LLC Aligns the Narrative
We bridge the gap between marketing ambition and regulatory reality.
- Claims vs. Codes Audit: We review your current marketing claims against your FDA Product Code definitions to identify drift or overreach.
- Name Synchronization: We update your FURLS listings to include all current commercial brand names, ensuring searchability and compliance.
- Advisory Review: We provide executive guidance on how to phrase claims so they remain compliant with your existing regulatory pathway.