From Registration to Governance: Keeping Your FDA Portfolio Clean
Your FDA profile is a living record. The most common compliance failures are not “big” mistakes—they are unmanaged changes: outdated contacts, legacy listings, and misaligned roles.
1) What “clean portfolio” means in practice
A clean FDA portfolio is internally consistent, current, and defensible. It aligns establishment roles to the real-world supply chain, eliminates duplicates, and maintains accurate ownership and contact data.
Signals of a Clean Portfolio
- Current contacts and responsible parties
- Listings match actual device commercialization
- No orphaned records or duplicate device entries
- Traceable rationale for every change
Signals of Portfolio Risk
- Legacy listings no one “owns” internally
- M&A activity without record updates
- Distributor-managed data with limited visibility
- Inconsistent naming and product coding
2) When you need portfolio cleanup
Cleanup is typically required after organizational change (new facilities, new ownership, new product lines) or when historical filings were executed without a governance framework. If you cannot answer “what is listed, why it is listed, and who owns it” with confidence, cleanup is justified.
3) Change control: what must stay current
Maintaining compliance requires a proactive approach to data updates. Critical fields that require constant monitoring include:
- Legal entity and facility identifiers
- U.S. Agent information (mandatory for foreign establishments)
- Device portfolio additions/removals and naming consistency
- Operational roles (Manufacturer vs. Spec Developer vs. Relabeler)
How BRS LLC Operationalizes Governance
We provide lifecycle coverage that keeps your FDA record stable over time through a structured accountability model.
- Portfolio Cleanup: We identify and resolve duplicates, gaps, and ownership issues.
- Maintenance Program: We implement change control and recurring validation workflows.
- Renewal Execution: Calendar governance combined with documented verification checks.
- U.S. Agent Coverage: Direct accountability for all official FDA communications.