FDA registration concepts, explained for busy device leaders.

This hub centralizes plain-language explanations of key U.S. FDA registration concepts: device listing, establishment registration, U.S. Agent, portfolio clean-up, and more. Each card outlines what it is, why it matters, and where to go next on BeaconFDA.com.

What is FDA Establishment Registration?

Establishment registration is how FDA knows who you are, where you operate, and what role you play in the device supply chain (manufacturer, specification developer, re-packer, relabeler, importer, etc.). It is the baseline requirement before shipping most devices into the U.S. market.

Beacon helps clarify which sites must register, how roles map to FEI numbers, and how to keep registrations aligned with your evolving footprint.

What is FDA Device Listing?

Device listing ties specific products to your registered establishments, including their product codes, regulation numbers, and, where applicable, 510(k) references. It is how FDA understands what you actually place on the U.S. market.

Beacon supports initial listings, updates, and corrections so your FDA portfolio reflects reality—across OEM, private-label, and complex supply chains.

What does a U.S. Agent actually do?

For non-U.S. manufacturers, a U.S. Agent is the designated regulatory point of contact for FDA—not your importer of record or commercial distributor. The Agent receives FDA correspondence and helps ensure you respond in a timely, structured way.

Beacon acts as a decisive, founder-led U.S. Agent focused on clarity, documentation, and readiness for inspections or import questions.

Why does “portfolio clean-up” matter?

Over years of launches, rebrands, acquisitions, and private-label deals, device listings become cluttered: duplicates, obsolete entries, misaligned product codes, and sites that no longer exist. This creates noise and risk during audits.

Beacon provides disciplined rationalization so your “active” FDA footprint matches what you actually sell and where.

How does regulatory strategy support growth?

Regulatory advisory connects the dots between your revenue plan and FDA expectations: which pathways are viable, what evidence you need, and how quickly you can expand indications without compromising compliance.

Beacon provides executive-level advisory for boards, investors, and commercial leaders who need clear trade-offs, not jargon.

How does FDA registration connect to your QMS?

Establishment registration and device listing are only one layer of FDA oversight. They sit on top of a quality management system that must meet 21 CFR 820. Misalignment between what you list and what your QMS controls can create vulnerability during inspections.

Beacon helps executives see registration data as part of the audit-readiness story, not a separate admin task.

How do importers, distributors, and OEMs fit together?

In many portfolios, OEMs, private-label partners, and importers all appear in FDA systems. Clarity on who lists what, under which FEI, and who holds which responsibilities is critical to avoid gaps or double-counting.

Beacon works with manufacturers and distributors to map roles, then adjust listings so supply-chain reality is reflected in FDA records.

What should non-U.S. manufacturers know first?

The critical sequence is: confirm device classification and pathway, identify whether a 510(k) or other submission is needed, then line up establishment registration, device listing, and U.S. Agent support before commercialization.

Beacon’s “Start Here” and “Who We Help” pages give non-U.S. teams a realistic first briefing on timing, dependencies, and responsibilities.

How should investors read FDA registration data?

For investors, clean FDA registration data is a leading indicator of execution discipline. Messy portfolios or unclear roles often signal operational debt that may surface during growth or inspections.

Beacon helps translate regulatory status into a concise risk and readiness story for capital providers.

How do we start a conversation with BRS LLC?

The fastest path is a structured intake: who you are, your device type, your U.S. timeline, and whether you need U.S. Agent, establishment registration, device listing, or portfolio clean-up.

Formal engagement documents and secure document exchange follow once we agree on scope.