Overview
Foreign manufacturers distributing medical devices in the United States are required by law to designate a US Agent — a US-based individual or entity who serves as FDA's primary point of contact. Mansour Consulting provides experienced, responsive US Agent and Official Correspondent services, ensuring your FDA obligations are met accurately and on time.
US Agent Services
As your FDA-designated US Agent under 21 CFR 807.40, we serve as the authorized point of contact between your company and the Food and Drug Administration.
- US Agent designation — FDA registration and documentation
- Receipt and forwarding of all FDA correspondence
- 24/7 availability for FDA emergency communications
- Annual FDA establishment registration (October 1 – December 31)
- Device listing updates and maintenance
- Coordination of FDA inspection logistics and communications
Official Correspondent (OC) Services
The Official Correspondent is the individual designated to receive regulatory correspondence from FDA. We ensure all communications are received, reviewed, and responded to promptly and professionally.
- Official Correspondent designation in FDA systems
- Management of FDA inquiries and correspondence
- Response drafting and regulatory guidance
- Coordination with your international regulatory team
FDA Establishment Registration & Device Listing
Every foreign manufacturer must register their establishment and list their devices with FDA annually. We manage this process completely.
- Initial establishment registration in FDA FURLS system
- Annual registration renewal (510(k) exempt and cleared devices)
- Device listing — FDA product codes, regulation numbers, DI numbers
- 510(k) number linkage and premarket submission tracking
- Owner/operator and US Agent updates
Registration failures can result in devices being refused entry at US ports of entry. We ensure your registration is always current.
Import/Export & Certificate to Foreign Government
We assist with the regulatory requirements that accompany cross-border movement of medical devices.
- Certificate to Foreign Government (CFG) application preparation
- Import alert review and admissibility assessment
- FDA Prior Notice coordination
- Export requirements and Certificate for Export
FDA Inspection Support
When FDA schedules an inspection of your foreign facility, having experienced US representation makes a significant difference.
- Pre-inspection readiness assessment
- FDA 483 observation response preparation
- Mock inspection facilitation
- On-site inspection support (travel available)