US · FDA Establishment Registration · Device Listing · 21 CFR Part 807
US FDA Establishment Registration & Device Listing for U.S. Companies
We provide consulting and documentation support so U.S. device companies know who must register, what to list, how to work in FDA’s FURLS/DRLM system, when to complete initial registration/listing (within 30 days), and how to stay compliant during the annual Oct 1–Dec 31 renewal—including the required establishment registration user fee. You keep control of the account and submissions; we make the process clear and audit-ready.
30-day initial registration & listing
FURLS/DRLM guidance
Annual Oct–Dec renewal & user fee
Audit-ready documentation
Why Establishment Registration & Device Listing Matter
If you manufacture, develop, relabel, or import medical devices in the U.S., registration and listing are not optional—they are required under 21 CFR Part 807 and must be kept current.
- Mandatory obligations: U.S. device establishments must register with FDA and list their devices; this applies to manufacturers, specification developers, contract manufacturers, repackers/relabelers, and U.S.-based initial importers.
- Deadlines apply: Initial establishment registration and device listing must be completed within 30 days of starting regulated device activities.
- Annual user fee: Each year, between Oct 1 and Dec 31, establishments must review/update registration and listings and pay the FDA establishment registration user fee. Registration cannot be completed until FDA receives and processes this fee.
- Online system: All registration and listing activities are managed through FURLS and the Device Registration & Listing Module (DRLM).
- Not an approval: Being registered or listed does not mean FDA has approved or cleared your devices; it only reflects that your establishment and devices are in FDA’s databases.
Who This Service Is For
We support U.S.-based companies that distribute devices commercially and want predictable, documented compliance.
- U.S. manufacturers and contract manufacturers of medical devices.
- Specification developers that have devices made under contract.
- Repackers and relabelers operating in the U.S. market.
- U.S.-based initial importers bringing foreign-manufactured devices into the country.
- Teams setting up device operations for the first time or formalizing compliance after rapid growth.
Consulting and documentation service only. We produce the BEP and BER, map your existing evidence, justify NA decisions, and highlight gaps. We do not perform laboratory testing, do not author label artwork, and do not act as a Notified Body. Your team owns testing decisions, laboratory contracts, and final submissions to authorities and Notified Bodies.
What You Will Receive
Deliverables are built around one goal: a clear, documented registration and listing process that your team can repeat every year.
Registration & Listing Plan
- Identification of which entities in your structure must register as establishments.
- Clarification of which devices must be listed and under which establishment.
- Timeline and responsibilities for initial registration/listing (30-day requirement) and annual Oct–Dec review.
FURLS/DRLM Walkthrough
- Guidance for setting up or confirming your Owner/Operator (O/O) account in FURLS.
- Field-level hints for completing DRLM screens for establishment registration and device listing.
- Notes on common data issues (wrong product codes, missing submission numbers) and how to avoid them.
Device Listing Worksheet
- Per-device worksheet capturing: product code, proprietary/brand name, activities (e.g., manufacturer, specification developer, repacker/relabeler, initial importer).
- Links to any applicable premarket submission numbers (510(k), De Novo, PMA) where required.
- Simple structure that can be reused as your product portfolio grows.
Annual User-Fee Checklist
- Step-by-step outline for paying the annual establishment registration user fee.
- Notes on timing, proof of payment, and how to ensure DRLM recognizes that the fee has been processed.
- Documentation format so finance and regulatory can both track completion.
Change-Log Template
- Template to record additions, discontinuations, and ownership/address changes affecting registration and listing.
- Columns for effective dates and internal approvals to support inspection readiness.
Annual Review Checklist (Oct–Dec)
- Structured checklist for verifying establishment data, device listings, and activities each year.
- Prompts for confirming user-fee payment and capturing proof.
- Simple record you can keep in your quality system as evidence of annual review.
Why Teams Choose Sobel for Independent ISO 10993-1 Gap Reviews
Sobel acts as a critical, precise external reader for your biological evaluation documentation—focusing on how reviewers interpret your files, not on selling generic tools.
- Independent perspective on how your dossiers align with the ISO 10993-1:2025 biological effects view and ISO 14971-style risk estimation.
- Tight focus on one outcome: a concise, prioritized gap report—not templates, scorecards, or ready-made drafts.
- Strong emphasis on how chemistry (ISO 10993-18) and toxicological risk assessment (TRA, ISO 10993-17:2023) support sufficiency judgments.
- Clear explanations of where rationales are robust, weak, or missing, written in reviewer-oriented language.
- Experience across multiple markets (EU, FDA, Brazil and others), reflecting how authorities frame ISO 10993-1 within the broader risk-management process.
How Our Establishment Registration & Listing Service Works
We move from a clear inventory of your activities and products to a repeatable registration and listing routine.
Discovery
- Confirm your establishment type(s) (manufacturer, specification developer, contract manufacturer, repacker/relabeler, initial importer).
- Review current registration/listing status (if any) and relevant premarket submission numbers.
- Collect a preliminary device list and commercial distribution status.
Data Preparation
- Gather Owner/Operator details and user access for FURLS/DRLM.
- Assemble product codes, regulatory classifications, and applicable 510(k)/De Novo/PMA numbers.
- Populate the device listing worksheet and change-log template from your internal data.
DRLM Guidance & Initial Registration/Listing
- Walk your team through FURLS/DRLM screens to register the establishment and list devices correctly.
- Provide field-level tips and examples while you enter data and submit under your credentials.
Annual Oct–Dec Cycle Setup
- Define your yearly Oct 1–Dec 31 review routine: who checks what, when, and how.
- Provide the annual user-fee checklist and documentation expectations.
- Align the change-log and annual review checklist with your quality system so you can show a clear history in audits.
What We Need From You
We rely on you for facts about your business and devices; we provide structure and guidance.
- Owner/Operator (O/O) details and access to your FURLS/DRLM account.
- A list of device-related activities performed at each U.S. site (manufacturing, specification development, repack/relabel, initial import).
- Device list with product names, intended use, and, where available, product codes and premarket submission numbers.
- Current registration/listing confirmations (if already in the system) and any known issues.
- Internal contacts responsible for regulatory, operations, and finance (for the user fee).
Consulting and documentation only. You hold and manage the FURLS/DRLM account, pay all fees directly to FDA, and submit registration and listing entries under your own credentials. Registration and listing do not mean FDA has approved or cleared your devices.
FREQUENTLY ASKED QUESTIONS
Within 30 days of starting device activities that fall under FDA’s medical device regulations. Establishment registration and device listing are typically done at the same time.
Every year between October 1 and December 31, you must review and update your establishment registration and device listings and pay the annual establishment registration user fee. If the fee is not paid and processed, registration cannot be completed.
No. Registration and listing do not indicate FDA approval, clearance, or endorsement. They simply show that your establishment and devices are recorded in FDA’s systems.
U.S. manufacturers, specification developers, contract manufacturers, repackers/relabelers, and initial importers that commercially distribute medical devices in the U.S. are typically required to register and list.
No. You hold and control your FURLS/DRLM account, submit all entries, and pay fees directly to FDA. We provide guidance, documentation, and review to make those submissions correct and complete.
No. This service is specifically for U.S.-based establishments. Concepts like a “U.S. Agent” are relevant for foreign establishments, not for U.S. companies.
Short Glossary
- Owner/Operator (O/O): The legal entity account used to access FURLS and manage registration and listing information.
- FURLS (FDA Unified Registration and Listing System): FDA’s online account system for registration and listing.
- DRLM (Device Registration & Listing Module): The FURLS module used specifically for medical device establishment registration and device listing.
- Initial registration & listing: The first registration and listing for a device establishment, required within 30 days of starting device activities.
- Annual review (Oct–Dec): The required yearly period to verify and update registration and listings and pay the establishment registration user fee.
- Not approval: A reminder that registration and listing do not equal FDA approval or clearance.
Get Your U.S. Establishment Registered and Your Devices Listed—Cleanly and On Time
Missing the 30-day window or the Oct–Dec annual renewal can create regulatory risk and confusion during inspections. We help you understand exactly who must register, which devices to list, how to work in FURLS/DRLM, and how to structure your annual user-fee payment and review routines—so your records stay current, defensible, and easy to explain.
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