Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all (I hope my anonymity is understandable here),

My UK company's U.S. Agent has seemingly disappeared without trace! Our manufacturing location is in the UK (medical device software), but we now have a subsidiary in the US for sales, etc. Can someone in this subsidiary be our U.S. Agent? Or do we even need a U.S. Agent? I'm struggling to find clarity on this here: U.S. Agents. Any further info anyone could point me to would be very welcome. 

Thanks in advance.

Foreign medical device manufacturers do require a US Agent, and the US Agent must be identified in the Establishment Registration.

As long as your US subsidiary can fulfill the role of the US Agent, then there's no reason that they can't act in that role. The FDA US Agent role is vastly different from EU Authorized Representative (AR) function. While the EU AR must be registered with their local competent authority, be on the device labeling, be made aware of vigilance activities, etc, the US Agent does not have similar responsibilities placed onto them.

As stated in the FDA's webpage on the role, whoever fulfills that role must:

• Reside in the US or maintain a place of business in the US (no post office box allowed)
• Cannot use an answering service, i.e., if the FDA calls, someone must be available to answer during regular business hours
• Assist in communications with the foreign establishment, including, as they mention, help to schedule an inspection, where the FDA requests to have the US Agent involved

That entity is obligated to support the FDA with the tasks specified above. However, unlike under the new EU MDR/IVDR, the US Agent doesn't hold liability for defective products, where the manufacturer fails to meet their obligations; does not need to be made aware, or involved in vigilance activities; does not need to be on the labeling; does not need to maintain technical documentation for the device.  

I previously worked for an organization that represented hundreds of companies as a US Agent, and generally where we would get involved is if there were questions by the customs agent, such as providing proof that the device is listed with the FDA. However, if your software is remotely downloaded, then this may not be applicable for you. As well, rarely but occasionally, to help schedule an overseas inspection or requests from the FDA. Otherwise, the manufacturer is typically able to handle communications directly with the FDA. You could proactively provide your US subsidiary information related to your Establishment Registration and device listing information from the completed registration so that they can address any questions that arise on the spot, if needed. However, they will have the time to also immediately email or call you, to get support to provide a fuller response back if/when needed.

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Sydney O'Connell
Director of Global Representation
Dallas TX
United States
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Original Message:
Sent: 01-Dec-2022 12:47
From: Anonymous Member
Subject: Subsidiary as/or U.S. Agent?

This message was posted by a user wishing to remain anonymous

Hi all (I hope my anonymity is understandable here),

My UK company's U.S. Agent has seemingly disappeared without trace! Our manufacturing location is in the UK (medical device software), but we now have a subsidiary in the US for sales, etc. Can someone in this subsidiary be our U.S. Agent? Or do we even need a U.S. Agent? I'm struggling to find clarity on this here: U.S. Agents. Any further info anyone could point me to would be very welcome.

Thanks in advance.

Hello Anon

That page on US Agents is probably the most helpful guidance. You might also look at the definitions here:
https://www.fda.gov/medical-devices/device-registration-and-listing/who-must-register-list-and-pay-fee

They'll clarify that you and your subsidiary are treated as separate entities, each having certain responsibilities.

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 01-Dec-2022 19:24
From: Sydney O'Connell
Subject: Subsidiary as/or U.S. Agent?

Foreign medical device manufacturers do require a US Agent, and the US Agent must be identified in the Establishment Registration.

As long as your US subsidiary can fulfill the role of the US Agent, then there's no reason that they can't act in that role. The FDA US Agent role is vastly different from EU Authorized Representative (AR) function. While the EU AR must be registered with their local competent authority, be on the device labeling, be made aware of vigilance activities, etc, the US Agent does not have similar responsibilities placed onto them.

As stated in the FDA's webpage on the role, whoever fulfills that role must:

• Reside in the US or maintain a place of business in the US (no post office box allowed)
• Cannot use an answering service, i.e., if the FDA calls, someone must be available to answer during regular business hours
• Assist in communications with the foreign establishment, including, as they mention, help to schedule an inspection, where the FDA requests to have the US Agent involved

That entity is obligated to support the FDA with the tasks specified above. However, unlike under the new EU MDR/IVDR, the US Agent doesn't hold liability for defective products, where the manufacturer fails to meet their obligations; does not need to be made aware, or involved in vigilance activities; does not need to be on the labeling; does not need to maintain technical documentation for the device.  

I previously worked for an organization that represented hundreds of companies as a US Agent, and generally where we would get involved is if there were questions by the customs agent, such as providing proof that the device is listed with the FDA. However, if your software is remotely downloaded, then this may not be applicable for you. As well, rarely but occasionally, to help schedule an overseas inspection or requests from the FDA. Otherwise, the manufacturer is typically able to handle communications directly with the FDA. You could proactively provide your US subsidiary information related to your Establishment Registration and device listing information from the completed registration so that they can address any questions that arise on the spot, if needed. However, they will have the time to also immediately email or call you, to get support to provide a fuller response back if/when needed.

------------------------------
Sydney O'Connell
Director of Global Representation
Dallas TX
United States

Original Message:
Sent: 01-Dec-2022 12:47
From: Anonymous Member
Subject: Subsidiary as/or U.S. Agent?

This message was posted by a user wishing to remain anonymous

Hi all (I hope my anonymity is understandable here),

My UK company's U.S. Agent has seemingly disappeared without trace! Our manufacturing location is in the UK (medical device software), but we now have a subsidiary in the US for sales, etc. Can someone in this subsidiary be our U.S. Agent? Or do we even need a U.S. Agent? I'm struggling to find clarity on this here: U.S. Agents. Any further info anyone could point me to would be very welcome.

Thanks in advance.

Original Message:
Sent: 12/1/2022 12:47:00 PM
From: Anonymous Member
Subject: Subsidiary as/or U.S. Agent?

This message was posted by a user wishing to remain anonymous

Hi all (I hope my anonymity is understandable here),

My UK company's U.S. Agent has seemingly disappeared without trace! Our manufacturing location is in the UK (medical device software), but we now have a subsidiary in the US for sales, etc. Can someone in this subsidiary be our U.S. Agent? Or do we even need a U.S. Agent? I'm struggling to find clarity on this here: U.S. Agents. Any further info anyone could point me to would be very welcome. 

Thanks in advance.

Agreed with the other great comments about the general role of a U.S. Agent.  However, I will say that even in today's modern digital age, I still routinely receive various questions from FDA regarding my foreign clients for whom my firm acts as the U.S. Agent.  More often than not, the questions have substantive compliance implications.  For example, as a U.S. Agent, I routinely receive and help resolve adverse event follow-up questions from FDA's CDRH OPEC Medical Device Reporting (MDR) Team.  And of course the infamous customs detainments too.  Some types of FDA correspondences seem to require written notice; accordingly, FDA it seems still prefers to send those letters to a U.S. Agent rather than via overseas/international delivery.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2022 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 02-Dec-2022 14:56
From: Christopher Smith
Subject: Subsidiary as/or U.S. Agent?

Let me preface my answer here by saying I'm a "drug" guy, not a "device" guy.  That said, I'm the US Agent for several firms on the drug side and the requirement is simply that an agent has be someone based in the US.  Frankly, I believe this is all fairly out-of-date given our ability to communicate globally these days.  The requirement goes back to the days FDA did not want to have to track down someone in some foreign country if the had a question or concern about the company's product or operations.  They wanted a "local" (i.e. US) contact.  That person may simply be just that – a contact (i.e. liaison) or more than that.  Could be an employee who is based in a company facility here in the US, or could just be a paid consultant who is just a contact, or more such as also someone who handles regulatory affairs, or quality assurance or other issues.  Based on my experience, it would be fine for you to name someone in the US subsidiary as the agent.

 

Original Message:
Sent: 12/1/2022 12:47:00 PM
From: Anonymous Member
Subject: Subsidiary as/or U.S. Agent?

This message was posted by a user wishing to remain anonymous

Hi all (I hope my anonymity is understandable here),

My UK company's U.S. Agent has seemingly disappeared without trace! Our manufacturing location is in the UK (medical device software), but we now have a subsidiary in the US for sales, etc. Can someone in this subsidiary be our U.S. Agent? Or do we even need a U.S. Agent? I'm struggling to find clarity on this here: U.S. Agents. Any further info anyone could point me to would be very welcome.

Thanks in advance.