Core Service

FDA Registration & Account Set-Up

Disciplined structure and documentation to begin commercialization without preventable rework.

FDA establishment registration is where many first-time U.S. entries lose time—typically due to unclear roles or data that is not yet decision-ready. Beacon Regulatory Services LLC (BRS LLC) sets up your FDA account footprint with disciplined structure, so you can avoid last-minute escalations or compliance drift.

Core Concepts

Establishment Registration

Your official FDA record as a device establishment doing business in the U.S. Registration is an annual obligation and must remain current as your company, sites, and responsibilities evolve.

Account Set-Up

The controlled setup of your FDA account footprint, roles, and key establishment details, so your portfolio activities (registration and listing actions) can be executed cleanly and maintained with traceability.

Who Needs This?

• First-time U.S. entrants needing a clean setup.
• Teams transitioning to repeatable operations.
• Companies adding sites or contract manufacturers.

What We Deliver

• Structured onboarding (only what FDA needs).
• Account set-up aligned to commercial models.
• Documentation designed for audit readiness.

Scope of Execution

✓ Intake & structure validation
✓ U.S. Agent alignment
✓ Registration readiness package
✓ Maintenance runbook

Roles & Responsibilities (RACI)

Clear accountability for every step of the process.

Area	Your Team	BRS LLC
Commercial Intent	Confirm portfolio & timelines.	Translate into an FDA registration plan.
Establishment Details	Provide legal entity details.	Validate completeness and structure.
Execution	Approve final decisions.	Execute set-up steps and produce records.
Maintenance	Notify changes (company, roles).	Maintain controlled updates and annual cycle.

Pricing & Coverage Options

Effort is driven by site count, complexity, and launch speed. (FDA fees are separate).

Starter

Single-site, simple footprint.

Custom / Setup

✓ Onboarding intake + validation
✓ Core registration readiness
✓ Setup runbook for continuity
✓ Basic change triggers defined

Request Proposal

Launch

Faster timeline, tighter governance.

Expedited / Pace

✓ Everything in Starter
✓ Accelerated execution cadence
✓ Role clarity + approvals model
✓ Portfolio organization approach

Inquire for Rates

Multi-Site

Complex structure or multiple entities.

Complex / Scope

✓ Multi-site scope mapping
✓ Governance + documentation pack
✓ Change management framework
✓ Operational handoff support

Need a clean FDA set-up?

Avoid downstream rework with a registration set-up that is accurate, documented, and decision-ready.

Frequently Asked Questions

What does “FDA registration” mean for medical devices?

It is the annual establishment-level record that positions your company in FDA’s device ecosystem and supports lawful U.S. distribution.

Is registration the same as FDA clearance or approval?

No. Registration is an administrative obligation. Clearance/approval relates to your device’s regulatory pathway and marketing authorization.

Who pays the FDA annual establishment fee?

Establishments required to register typically pay the annual fee directly to FDA. BRS LLC supports execution and documentation, not fee collection.

What information do you need from us to start?

Core establishment details, ownership/contacts, your operational model (sites/partners), and portfolio intent. We keep intake focused and decision-ready.

How long does registration and set-up typically take?

Timelines depend on establishment complexity and decision readiness. We scope and sequence work so you get a predictable launch plan.

What are the most common set-up failure points?

Unclear establishment roles, inconsistent company/site details, and portfolio information that is not aligned to how you operate commercially.

Do non-U.S. manufacturers also need a U.S. Agent?

Yes, foreign establishments typically require a U.S.-based communications conduit. BRS LLC can support as U.S. Agent depending on your scope.

Can you help us plan a clean annual renewal cycle?

Yes. We build a simple operating rhythm with triggers, timelines, and evidence so renewals don’t become a scramble.

What if our footprint changes after set-up?

We structure set-up with change control in mind, so additions (sites/partners/portfolio) can be implemented without destabilizing your FDA record.

Why choose BRS LLC for registration set-up?

We bring senior regulatory leadership and disciplined execution—so your FDA foundation is clean, auditable, and aligned to how you plan to scale.