Methodology
The BRS Operating System: a four-phase model that stabilizes your FDA record and keeps it clean over time.
FDA Advisory · Device Listing · U.S. Agent · Market Entry
Beacon Regulatory Services LLC is your U.S. FDA market-entry and governance partner.
Beacon Regulatory Services LLC helps manufacturers enter, scale, and defend their U.S. and North American footprint—through disciplined regulatory architecture and senior-led execution.
Built for foreign manufacturers and U.S. importers who need fast execution, documented control, and an accountable regulatory interface—without building an internal regulatory department.
Foreign Manufacturers · U.S. Importers · Distributors · Buyers
Regulatory clarity that keeps your FDA footprint clean.
What we do for medical device companies
Beacon Regulatory Services LLC is your FDA-facing regulatory partner for medical devices. We help you establish and maintain a clean U.S. compliance footprint—so you can stay focused on product quality, innovation, and growth.
Whether you are entering the U.S. for the first time or rationalizing an existing portfolio, we translate FDA requirements into a clear, actionable plan.
Fast onboarding for FDA timelines
A tight, audit-minded engagement flow.
Why choose us
Fast, compliant execution—without the noise.
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Fast onboarding
Rapid intake, clear requirements, and immediate execution for demanding FDA timelines.
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Audit-ready discipline
Documentation clarity, traceability, and portfolio accuracy you can defend.
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Responsive coverage
Short feedback loops, proactive follow-ups, and clear next steps.
How we deliver
Boutique service. Corporate-grade outputs.
We prioritize speed, clarity, and accountable execution—built for manufacturers who need results, not layers.
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Inspection-ready mindset
Structured documentation and traceability from Day 1.
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No fluff execution
Clear deliverables, clear owners, clear closure.
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Pragmatic pathways
Decision-ready guidance aligned to FDA realities.
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Fast response cycle
Short loops, proactive follow-up, rapid iteration.
BeaconFDA
What we are known for in the industry
Founder-led, FDA-facing execution—built on direct experience with U.S. registrations and listings, 510(k) pathways, eMDR responses, and audit-ready lifecycle controls. We keep your regulatory footprint accurate, current, and defensible under real-world timelines.
BeaconFDA
Where our clients come from
We support international manufacturers and U.S. sponsors that need a clear, accountable FDA-facing partner— especially when timelines are tight and portfolio accuracy matters.
Europe · Foreign manufacturers
Asia · OEM / contract manufacturing
Latin America · Importers
U.S. · Startups & sponsors
Client Engagement Scenarios
We replace regulatory uncertainty with commercial confidence. These case studies illustrate how we navigate the intersection of FDA requirements and business reality to keep products moving.
Registration · U.S. Agent
Initial FDA registration after prior vendor delays
Rapid triage, clean establishment record, and a defensible U.S. Agent setup.
Read their story →
Listing · Portfolio
Portfolio clean-up to align listings to the live catalog
Retired obsolete listings and remapped products to the right codes and owners.
Read their story →
Renewal · Continuity
Renewal readiness under compressed timelines
Locked data, verified FEI/owner/operator details, and avoided last-minute rework.
Read their story →
Strategy · Submissions
Pathway decision: exempt vs. 510(k) for a change scenario
Clarified regulatory posture and documented a pragmatic, audit-ready rationale.
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Lifecycle · Compliance
Lifecycle controls to stay inspection-ready
Supported change control, labeling updates, and documentation hygiene.
Read their story →
Market entry · U.S.
Importer/distributor onboarding for FDA visibility
Established roles, data ownership, and listing clarity across stakeholders.
Read their story →
Ready to move with FDA timelines
Let’s align scope and move fast
Beacon Regulatory Services (BRS) LLC provides U.S. Agent coverage and device listing execution designed to stay clean over time—so your FDA footprint remains current, defensible, and inspection-ready.
- Fast support
- Clear accountability
- Audit-ready execution
Request a consult →
Typical next step: 15–20 minute intake to confirm scope, timelines, and data readiness.
Executive Briefing: Vol. 01 The "Phantom" Listing Risk: Governance & Liability in Legacy FDA Portfolios Verified Analysis: 21 CFR 807 FDA DRLM M&A Diligence Executive Summary "Phantom" listings represent a latent liability in medical device portfolios—active FDA registrations for products that are no longer manufactured, creating risk during M&A due diligence, establishment inspections, and post-market surveillance. Under 21 CFR Part 807 , device manufacturers and initial importers are required to register their establishments and list each device they place into commercial distribution with the U.S. Food and Drug Administration (FDA). When those records are not updated as portfolios evolve, the official FDA view of the business drifts away from reality. Devices that have been retired, divested, or moved to another legal manufacturer remain “alive” in public databases, while some revenue-critical SKUs may be under-documented or associated with the wrong site or role. FDA has emphasized that incomplete or inaccurate registration and listing information can contribute to devices being misbranded under section 502(o) of the Federal Food, Drug, and Cosmetic Act, with enforcement consequences that include refusal of import, warning letters, and disruption of distribution. A consistent message across FDA regulations and implementation rules is that the Agency relies on complete and accurate registration and listing as the backbone for risk-based inspection, recall management, and post-market signal evaluation ( FDA Device Registration & Listing Overview ). The Hidden Liability of "Ghost" Data At the most basic level, a “phantom” listing is an FDA device listing that remains active in the Device Registration and Listing Module (DRLM) even though the underlying SKU has been retired, transferred, or completely redesigned. The database still shows the device as available under a specific establishment, product code, and role—even when the commercial catalog and technical file say otherwise. This disconnect is not simply cosmetic. Registration and listing data feed directly into FDA’s risk-based inspection planning, field alert response, and recall classification processes ( FDA Post-market Requirements ). When the Agency plans an establishment inspection, the scope is often anchored to the firm’s active product listing profile. If that profile includes “ghost” devices, investigators may expect to see manufacturing controls, risk files, and complaint handling for products that, in reality, have not been built for years. The result is unnecessary friction: time wasted during inspections explaining legacy history, scrambling to reconstruct records, and, in some cases, receiving Form FDA 483 observations for inadequate controls over registration and listing or incomplete technical documentation. Analysis Profile Focus Compliance Risk Data Source FDA DRLM Review Cycle Annual Req. FIG 1.1: Data Drift Correlation in M&A Legacy Listings vs. Post-Acquisition Integration Source: FDA DRLM Database Analysis (2024) – bit.ly/fda-drlm When Phantom Listings Surface Consider a composite but realistic scenario shaped by public FDA expectations and inspection trends. A mid-sized European manufacturer acquires a U.S. respiratory portfolio from a larger multinational. Commercially, the integration appears smooth: SKUs are migrated into the buyer’s ERP, sales teams are trained, and obsolete product lines are quietly retired. From a regulatory data perspective, however, little changes. Years later, FDA’s DRLM still shows multiple “Active” listings under the seller’s legacy establishment for SKUs that have not been manufactured in half a decade. During a subsequent pre-acquisition diligence by a private equity (PE) fund, the investors run a simple cross-check: public FDA listings vs. the target’s current catalog and revenue file. The result is a long list of “phantom” devices, mismatched roles, and establishments that appear to be legal manufacturers, even though all production has moved to a different site. The issue quickly escalates from a back-office cleanup item to a valuation lever in the deal model. In parallel, an FDA establishment inspection—initiated based on the legacy listing profile—arrives at one of the historic U.S. sites. Investigators expect to see quality system documentation, device master records, and servicing records for devices that the site no longer touches. The firm spends valuable inspection time walking through old transfers, divestitures, and discontinued lines instead of demonstrating control over the current portfolio. The story ends with corrective actions, a prolonged integration workstream, and a deal that closes—but with a haircut and expanded escrow tied to regulatory clean-up. The Anatomy of Regulatory Debt Regulatory debt is the compliance analogue of technical debt: short-term decisions that accelerate commercial execution but create structural clean-up work later. Phantom listings typically arise during three specific corporate events: M&A Transitions: Legacy listings remain under the seller’s establishment, or both seller and buyer list the same device for overlapping periods, creating ambiguity about who is responsible for current post-market obligations. Portfolio Rationalization: Product families are removed from brochures or GPO contracts, but the decommissioning of associated listings is never formally triggered in any SOP. Site Consolidations: Manufacturing moves to a new facility, but the original site continues to appear in DRLM as “Manufacturer” or “Specification Developer”, confusing both regulators and internal stakeholders. 38% of Inspection Observations Weaknesses in registration and listing control often sit upstream of broader documentation gaps. When sites cannot clearly explain which products are currently in scope—and why legacy devices remain visible—inspectors are more likely to probe the completeness of design history files, risk management documentation, and complaint trending. For manufacturers, cleaning up registration and listing is a relatively low-cost way to reduce the likelihood and impact of avoidable Form FDA 483 observations tied to documentation inconsistencies. Valuation Impact For investors, cluttered listing profiles are a visible proxy for governance maturity. When DRLM data does not align with the intended portfolio, deal teams assume similar drift may exist in quality records, supplier files, or labeling controls. In practice, this can translate into lower enterprise value, expanded indemnities, or covenants requiring post-close remediation before the next growth milestone. Governance Playbook: From Clean-Up to Prevention Leadership teams that successfully mitigate “Phantom” risk treat registration and listing as a governed lifecycle process, not an administrative afterthought. A practical operating model can be built around five disciplined steps: Single Source of Truth: Establish a master data view that maps marketed SKUs and Global Trade Item Numbers (GTINs) directly to FDA listing numbers, product codes, and roles. This view should be reconciled against FDA’s public database at least annually. Supply Chain Mapping: Confirm that the roles reflected in DRLM (“Manufacturer”, “Specification Developer”, “Initial Importer”) match the real supply chain and quality agreements. Where contract manufacturers are involved, roles should align with responsibilities defined in 21 CFR Part 820 or ISO 13485-aligned quality system documentation. Decommissioning Protocol: Codify a formal trigger in design control and lifecycle procedures so that when a product is discontinued, divested, or moved to another establishment, the corresponding listing update is initiated, documented, and closed within defined timelines. M&A Integration: Add registration and listing reconciliation to Day 1 integration checklists. For each transaction, the combined portfolio should be reviewed against the DRLM profile to identify duplicate, obsolete, or misaligned entries before the first post-close inspection. Governance Rhythm: Implement a semi-annual (or at minimum annual) review of registration data that includes Regulatory Affairs, Quality, Supply Chain, and Commercial. This cross-functional review should be documented as part of management review under the quality system. Embedding Phantom-Risk Prevention into the Quality System Ultimately, eliminating phantom listings is less about one-time clean-up and more about designing a system that makes data drift unlikely. The most resilient manufacturers embed registration and listing checkpoints into existing quality system processes: design transfer, change control, portfolio rationalization, and management review. For example, when a product is obsoleted through change control, the same workflow can automatically trigger an assessment of whether its listing should be updated or retired. When a new contract manufacturer is qualified, part of the supplier onboarding checklist can include confirming that roles and establishments are correctly reflected in FDA databases. When management reviews post-market surveillance trends, they can also review whether the public portfolio footprint still matches the risk profile they believe they are managing. For PE-backed platforms and serial acquirers, this discipline also becomes a differentiator. A clean, well-governed registration and listing footprint signals to future buyers—and to FDA—that the organization understands its own portfolio and is serious about lifecycle accountability. Advisory Services Stabilize Your Regulatory Footprint Beacon Regulatory Services LLC specializes in the reconciliation of legacy portfolios for global manufacturers and PE firms. We replace administrative uncertainty with audit-ready precision—cleaning up historical listings and designing governance so that phantom listings do not re-appear. Engagement Workflow 01. Portfolio Review & Mapping 02. Gap Analysis & Risk ID 03. Remediation & Governance Request a Diagnostic Consult
Investment Readiness What Investors and Strategic Buyers Expect from Your FDA Registration Story In medical device M&A, regulatory due diligence is often where deal value erodes. Investors and strategic buyers are not just looking at your IP; they are looking for liability. A messy FDA registration history suggests operational sloppiness that translates directly into post-close risk. Smart buyers look for a "Clean Chain of Custody" in your regulatory data. They want to see that every product you sold was properly listed, every facility was registered, and every change was documented. Gaps in this history—such as selling a device for two years before listing it—create "legacy liability" that buyers will price into the deal (or use to demand larger escrows). The Three Pillars of a Deal-Ready Profile 1. Rationalized Portfolio: Buyers want to know exactly what is active. If your FURLS account is cluttered with 50 dormant SKUs and old contract manufacturers, it signals a lack of lifecycle control. A lean, accurate listing profile demonstrates governance. 2. Clear U.S. Agent Agreements: For foreign targets, buyers scrutinize the U.S. Agent arrangement. Is it a professional firm, or a random distributor? Professional representation suggests that FDA correspondence has been handled correctly, reducing the risk of hidden warning letters. 3. Import Integrity: A history of smooth customs clearances is a valuable asset. Frequent holds or detentions due to registration errors suggest supply chain fragility that a buyer will have to fix. BRS LLC: Your Pre-Transaction Partner We help founders and PE firms prep the regulatory deck before the data room opens. Mock Diligence Audit: We review your public FDA data exactly as a buyer's auditor would, finding and fixing red flags early. Portfolio Rationalization: We clean up your device listings to present a tight, active commercial portfolio that matches your revenue projections. Transition Support: Post-deal, we manage the seamless transfer of registrations and listings to the new owner’s account structure. Clean Up Portfolio Clean-Up → Rationalize listings before the deal. Audit Executive Advisory → Pre-transaction regulatory health checks. Transition Registration Transfer → Smoothly migrate accounts post-close.
Global Strategy Building a North America Regulatory Rail: Coordinating FDA, Health Canada, and COFEPRIS for Scale For manufacturers eyeing North American expansion, the U.S., Canada, and Mexico represent a massive integrated market. However, treating them as a single regulatory block is a mistake. While MDSAP harmonizes quality systems, the registration and representation requirements for each country remain distinct—and often contradictory. Building a coherent "regulatory rail" means designing a system where a single product change (e.g., a new manufacturing site) triggers the correct, synchronized updates across all three jurisdictions. Failure to coordinate leads to fragmented inventory, where "Lot A" can only be sold in the U.S. while "Lot B" sits in a Canadian warehouse waiting for a license amendment. The Representation Puzzle The core friction point is local representation. In the U.S., you need a U.S. Agent (who handles communication but doesn't hold the license). In Canada, you need a Regulatory Correspondent (often tied to the MDL holder). In Mexico, you need a Registration Holder (who legally owns the registration). If you rely on three different distributors to fill these roles, you lose control of your intellectual property and your ability to switch partners. You become a hostage to your distribution channel. Centralized Control The executive solution is to separate *regulatory representation* from *commercial distribution*. By holding your own registrations (or using a neutral third-party holder) and appointing independent agents, you maintain the flexibility to change distributors without losing market access. This creates a stable "rail" for your products to ride on, regardless of who is selling them. How BRS LLC Coordinates the Continent We provide the central governance to manage multi-country compliance. Unified Representation: We serve as your U.S. Agent and coordinate with Canadian/Mexican counterparts to ensure consistent messaging to all three agencies. Change Management: When you change a label or site, we map the impact across FDA, Health Canada, and COFEPRIS to prevent compliance gaps. Distributor Independence: We help you structure registrations so you retain ownership, protecting your market access rights. Expand North America Expansion → Coordinated FDA, Health Canada, and COFEPRIS strategy. Plan Executive Advisory → Structuring distributor-independent market access. Anchor U.S. Agent Services → Your stable anchor for the U.S. market.
Marketing Compliance Your Website, Your Labeling, and Your Device Listing: Why FDA Cares if the Story Doesn’t Match Marketing teams want to sell features. Regulatory teams need to defend indications. When these two narratives drift apart, you create a "misbranding gap"—and your public Device Listing is often the evidence FDA uses against you. Every FDA Device Listing is tied to a specific Product Code (ProCode) and Regulation Number. These codes carry inherent definitions of what the device is and what it does. If your marketing materials or website claims begin to drift outside those definitions—promoting a "wellness" device for disease treatment, or a Class I exempt device for a high-risk indication—you are effectively marketing an unapproved device. This misalignment is one of the most common triggers for Warning Letters. FDA's automated tools and reviewers routinely check manufacturer websites against their FURLS listings. If your website promises "AI-driven diagnostics" but your listing is for a generic "medical image management system," the discrepancy is obvious. The listing itself becomes proof that you have introduced a new intended use without a new 510(k). The Proprietary Name Trap Another frequent issue is the "Proprietary Name" field in FURLS. Manufacturers often list a device under an internal project code or an old brand name, while the website uses a flashy new commercial name. If a hospital or FDA investigator searches for your new brand and finds nothing in the database, they assume the device is unregistered. Keeping your proprietary names synchronized across labeling, web, and FURLS is a basic but critical compliance control. How BRS LLC Aligns the Narrative We bridge the gap between marketing ambition and regulatory reality. Claims vs. Codes Audit: We review your current marketing claims against your FDA Product Code definitions to identify drift or overreach. Name Synchronization: We update your FURLS listings to include all current commercial brand names, ensuring searchability and compliance. Advisory Review: We provide executive guidance on how to phrase claims so they remain compliant with your existing regulatory pathway. Check Claims Regulatory Advisory → Ensure claims align with your product codes. Fix Names Listing Portfolio Clean-Up → Sync FURLS names with your website brands. Foundation Establishment Registration → Maintain a clean baseline registration.
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