FDA U.S. Agent Change & Update for Foreign Manufacturers
If you are already registered and listed with FDA but need to replace your U.S. Agent or fix their contact details, we handle the change from end to end. We guide the edit in FDA’s Device Registration & Listing Module (DRLM), receive and confirm the new agent appointment using FDA’s Receipt Code email within 10 business days, and verify that your record correctly routes FDA messages to Sobel as the U.S. Agent.
U.S. Agent change executed in DRLM
10-business-day confirmation handled
Optional Official Correspondent alignment
Record verified for correct routing
When You Need to Change or Update Your U.S. Agent
This service is for foreign device manufacturers who are already in FDA’s system and want to make sure the right U.S.-based contact is on record.
- You want to replace a prior U.S. Agent with Sobel as your new agent.
- Your current U.S. Agent’s email, phone, or address is outdated or incorrect in DRLM.
- Internal responsibility for FDA communications has shifted and needs a clean handover.
- You are in the Annual Registration window and want to tidy up your U.S. Agent details at the same time.
What You Will Receive
We focus on the specific steps that make the U.S. Agent change effective and verifiable.
DRLM Change Executed
- Clear, step-by-step instructions and screenshots for editing U.S. Agent fields under “Change Registration Information” in DRLM.
- Guidance on when to perform the change immediately vs. aligning it with the Annual Registration review (Oct 1–Dec 31).
- Cross-check so establishment, U.S. Agent, and other contact details remain internally consistent.
Agent Confirmation Handled
- Sobel receives FDA’s U.S. Agent Receipt Code email after you update the DRLM record.
- Confirmation is completed within the 10-business-day window so the association becomes active.
- Monitoring in case the Receipt Code must be re-sent due to typos or routing errors.
Former Agent Handoff
- Optional email language to notify your previous U.S. Agent that the role has changed.
- Reminder that a prior agent can discontinue the association in DRLM if needed.
- Practical tips to close out old inbox rules and avoid split or duplicated communications.
Post-Change Verification
- Check of your FDA registration record to confirm Sobel appears as the U.S. Agent with correct contact details.
- Optional alignment of Official Correspondent settings if you want a single primary contact path.
- Short confirmation summary you can keep in your quality and regulatory files.
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 the U.S. Agent Change Service Works
We turn the DRLM update and 10-day confirmation into a controlled mini-project.
Discovery & Planning
- Collect your Owner/Operator number, DRLM account owner, facility details, and current U.S. Agent information.
- Clarify whether the change should happen immediately or during the Annual Registration window.
DRLM Edit & Agent Change
- Ensure data entered matches the agreed Sobel contact information exactly (to avoid Receipt Code issues).
- Guide your DRLM account owner through “Change Registration Information” to update U.S. Agent name and contact details to Sobel.
Receipt Code & Confirmation
- We complete the required confirmation within 10 business days so the change is accepted and the link is finalized.
- Sobel receives the U.S. Agent Receipt Code email from FDA.
Verification & Handoff
- Provide optional wording for contacting the former agent and an internal summary for your QA/RA records.
- Verify that DRLM shows Sobel as the active U.S. Agent and, if desired, as Official Correspondent.
What We Need From You
We keep your input focused on the minimum information needed to execute a clean change.
- Owner/Operator number and DRLM account owner details (who can log in and edit the registration).
- Facility details (legal name, address) and the current U.S. Agent information on file.
- Primary contact(s) on your side for FDA and import-related topics (regulatory, quality, operations).
- Preferred Official Correspondent setup—whether you want Sobel to hold that role as well.
FREQUENTLY ASKED QUESTIONS
Yes. Foreign medical device establishments that import or offer devices for import into the U.S. must designate one U.S. Agent in their FDA registration.
Your DRLM account owner updates the U.S. Agent fields via “Change Registration Information.” After that, FDA emails the new U.S. Agent a Receipt Code. The new agent uses that code to confirm the appointment and finalize the link.
The U.S. Agent must confirm within 10 business days from the date FDA sends the Receipt Code email. If not confirmed in time, the code is cancelled and the association is removed; you must then update the registration again.
Yes. You can update your U.S. Agent on the Annual Registration review page during the Oct 1–Dec 31 annual registration window. Many companies combine agent changes with their yearly review.
The change affects where FDA sends communications and inspection scheduling notices, not the underlying device listings or marketing authorizations. Those remain in place as long as your registration and listing are current.
Keep FDA Communications Flowing to the Right U.S. Agent
If your current U.S. Agent is outdated, unresponsive, or simply not the right fit anymore, your FDA communications are at risk. Sobel helps you update the U.S. Agent entry in DRLM, completes the mandatory 10-business-day confirmation, supports communication with your former agent, and verifies that FDA will use the correct contact going forward.
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