Entering the U.S. Medical Device Market: A Practical FDA Onboarding Playbook
If you are new to the U.S. market, the fastest way to stay compliant is to treat establishment registration, device listing, and U.S. Agent designation as a single, governed onboarding workflow.
1) What you must do before commercial distribution
For most manufacturers, U.S. market entry begins with three operational deliverables: (1) establishment registration, (2) device listing, and (3) U.S. Agent designation (for foreign establishments). These are foundational data obligations that enable FDA visibility and downstream import screening alignment.
2) Establishment registration: who needs it
Establishment registration identifies the legal entity and facility context under which a medical device is manufactured, processed, or distributed. Whether you register depends on your role and where activities occur.
Typical registration inputs
- Company and facility identifiers
- Role/activity selection
- U.S. Agent information
- Device linkage
Common pitfalls
- Incorrect activity selection
- Supply chain mismatches
- Outdated contact data
- Duplicated records
3) Device listing: what “clean” looks like
A clean device listing portfolio is internally consistent, current, and defensible. It matches your classification, product code, and proprietary naming conventions. Clean listings reduce import friction and simplify audits.
How BRS LLC Supports Your Onboarding
We align scope quickly to establish a clean, controlled registration and listing baseline for first-time U.S. entry.
- U.S. Agent Coverage: Accountable communications interface with the FDA.
- Establishment Registration: Professional role mapping and submission.
- Device Listing: Strategic portfolio build and data validation.
- Maintenance & Renewal: Continuous lifecycle support.