Cleaning Up Legacy FDA Device Listings After M&A, Distributor Changes, or Product Discontinuations
Inherited regulatory data is rarely clean. Whether through M&A, distributor churn, or strategic pivots, most portfolios accumulate "ghost listings"—records of devices you no longer sell, made at facilities you no longer own. These artifacts are not harmless; they are active liability magnets.
For Private Equity firms and corporate RA/QA leaders, the integration phase of an acquisition often focuses on financials and key personnel. The FURLS (FDA Unified Registration and Listing System) account is frequently ignored until a crisis hits. We often see portfolios where 30-40% of the active listings represent discontinued SKUs or divestitures that were never properly deactivated.
The risk is tangible. If you list a device, you are telling FDA you currently market it. This means you are responsible for its complaint handling, adverse event reporting (MDR), and recall execution. If a "ghost" product you thought was dead shows up in a hospital complaint, and you have no active quality data for it, you have just handed an FDA investigator a finding for "Failure to Maintain Complaint Files."
The Clean-Up Phasing Strategy
Cleaning up a messy portfolio requires a phased approach, not a "delete all" button. First, verify inventory: ensure no residual stock exists in the supply chain. Second, check open field actions: you cannot deactivate a listing that is subject to an open recall. Third, coordinate with contract manufacturers: if you delist, they must also update their records to avoid a mismatch.
How BRS LLC Restores Order
We treat your FURLS account like a financial ledger—it must balance.
- Full Portfolio Audit: We extract your total listing history and cross-reference it against your current ERP sales data to identify "zombie" products.
- Deactivation Governance: We execute the deactivations in FURLS, ensuring the proper "end marketing date" is recorded to maintain a compliant history.
- M&A Integration: For new acquisitions, we migrate listings to your primary Owner/Operator account, consolidating your regulatory footprint for easier oversight.