Device Listings for OEMs, Contract Manufacturers, and Private Labelers: Whose Name Goes Where?
In modern medical device manufacturing, the company that designs the device, the company that builds it, and the company that brands it are often three different entities. This complexity creates a "listing gap"—a misalignment in FURLS that can lead to misbranding allegations or inspection 483s.
The FDA requires transparency about who is doing what. "Legal Manufacturer" on a label implies responsibility for design and complaint handling. "Contract Manufacturer" implies building to another’s specification. If your FURLS registration says one thing but your label says another, you have a problem.
The Common Traps
1. The "Ghost" Manufacturer: A brand owner (Specification Developer) lists a device, but their Contract Manufacturer fails to list the same device. FDA regulations require the contract manufacturer to list the device they build, even if they don't own the 510(k).
2. The Private Label Confusion: A distributor buys a finished device and puts their own brand on it. They often think they are just a "Relabeler/Repackager." However, if they change the Intended Use or claim ownership of the design, they may inadvertently become the "Manufacturer" in FDA's eyes, triggering full Quality System (21 CFR 820) obligations they aren't ready for.
3. Kitting & Packs: Companies that assemble kits often fail to list the kit itself, only listing the components. This breaks the traceability chain.
How BRS LLC Cleans Up the Chain
- Role Audits: We review your supply chain contracts and labeling to determine the exact FURLS role for each entity (e.g., Manufacturer vs. Specification Developer).
- Listing Synchronization: We ensure that the Contract Manufacturer’s listing points to the Brand Owner’s listing, creating the "linkage" FDA looks for.
- Portfolio Clean-Up: We retire old listings from fired suppliers and set up new ones for current partners, ensuring your FDA profile matches your actual ledger.