Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello All!

is there anybody of the Team able to support me with  the functions and responsibilities of the US Agent and designated US Agent for foreign establishments?

In the FDA website under the link:

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053196.htm

the function and responsibilities of the US Agent are stated, which includes rather a communication role. It is also stated that the US Agent has no responsibilities related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E). This US Agent has to reside or maintain a business at USA and any changes can be updated electronically at the FURLS.

In the CFR 21Part 803 the requirements of a designated US Agent  which is responsible for reporting adverse events and submitting 510k  are stated and that the information about who is the designated US Agent has to be provided to FDA by letter as well as any change of this person. 
It is my understanding that this designated US Agent with reporting and submission responsibilities has not to be reside in the USA, that means that a person at the foreign manufacturer facility can be assigned as designated US Agent. 

Does this information and my understanding reflects the FDA requirements or I am missing something?

Any reliable reply is very much appreciated.

Thank you!

Kind regards,

There are many qualified individuals/firms who provide U.S. Agent services.  ComplianceAcuity is one of them, as are a number of the other contributors to this Forum.

​FDA's MDR Policy Branch has stated that U.S. Agents responsible for submitting MDRs are no longer required.

Hope this helps,

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
------------------------------

Original Message:
Sent: 25-Jun-2017 10:19
From: Anonymous Member
Subject: US Agent and designated US Agent for foreign establishments

This message was posted by a user wishing to remain anonymous

Hello All!

is there anybody of the Team able to support me with  the functions and responsibilities of the US Agent and designated US Agent for foreign establishments?

In the FDA website under the link:

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053196.htm

the function and responsibilities of the US Agent are stated, which includes rather a communication role. It is also stated that the US Agent has no responsibilities related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E). This US Agent has to reside or maintain a business at USA and any changes can be updated electronically at the FURLS.

In the CFR 21Part 803 the requirements of a designated US Agent  which is responsible for reporting adverse events and submitting 510k  are stated and that the information about who is the designated US Agent has to be provided to FDA by letter as well as any change of this person. 
It is my understanding that this designated US Agent with reporting and submission responsibilities has not to be reside in the USA, that means that a person at the foreign manufacturer facility can be assigned as designated US Agent. 

Does this information and my understanding reflects the FDA requirements or I am missing something?

Any reliable reply is very much appreciated.

Thank you!

Kind regards,

Original Message------

This message was posted by a user wishing to remain anonymous

Hello All!

is there anybody of the Team able to support me with  the functions and responsibilities of the US Agent and designated US Agent for foreign establishments?

In the FDA website under the link:

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053196.htm

the function and responsibilities of the US Agent are stated, which includes rather a communication role. It is also stated that the US Agent has no responsibilities related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E). This US Agent has to reside or maintain a business at USA and any changes can be updated electronically at the FURLS.

In the CFR 21Part 803 the requirements of a designated US Agent  which is responsible for reporting adverse events and submitting 510k  are stated and that the information about who is the designated US Agent has to be provided to FDA by letter as well as any change of this person. 
It is my understanding that this designated US Agent with reporting and submission responsibilities has not to be reside in the USA, that means that a person at the foreign manufacturer facility can be assigned as designated US Agent. 

Does this information and my understanding reflects the FDA requirements or I am missing something?

Any reliable reply is very much appreciated.

Thank you!

Kind regards,

Regarding the MDRs, they must be submitted electronically to the Agency.

We can provide US Agent services plus submission of electronic regulatory documents.

Thank you.

Sincerely yours, Suzanne

------------------------------
Suzanne Sensabaugh
President and Principal Consultant
Hartmannwillner LLC
Washington DC
United States
------------------------------

Original Message:
Sent: 25-Jun-2017 10:19
From: Anonymous Member
Subject: US Agent and designated US Agent for foreign establishments

This message was posted by a user wishing to remain anonymous

Hello All!

is there anybody of the Team able to support me with  the functions and responsibilities of the US Agent and designated US Agent for foreign establishments?

In the FDA website under the link:

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053196.htm

the function and responsibilities of the US Agent are stated, which includes rather a communication role. It is also stated that the US Agent has no responsibilities related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E). This US Agent has to reside or maintain a business at USA and any changes can be updated electronically at the FURLS.

In the CFR 21Part 803 the requirements of a designated US Agent  which is responsible for reporting adverse events and submitting 510k  are stated and that the information about who is the designated US Agent has to be provided to FDA by letter as well as any change of this person. 
It is my understanding that this designated US Agent with reporting and submission responsibilities has not to be reside in the USA, that means that a person at the foreign manufacturer facility can be assigned as designated US Agent. 

Does this information and my understanding reflects the FDA requirements or I am missing something?

Any reliable reply is very much appreciated.

Thank you!

Kind regards,

​An additional clarification regarding the U.S. designated-agent responsibilities you recited from 803.58:   Those requirements were stayed indefinitely back in 1996, with reaffirmation of the indefinite stay in 2014.  Therefore at this time, firms are permitted to exclude the 803.58 obligations from their Part 803 compliance efforts.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com
------------------------------

Original Message:
Sent: 25-Jun-2017 10:19
From: Anonymous Member
Subject: US Agent and designated US Agent for foreign establishments

This message was posted by a user wishing to remain anonymous

Hello All!

is there anybody of the Team able to support me with  the functions and responsibilities of the US Agent and designated US Agent for foreign establishments?

In the FDA website under the link:

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053196.htm

the function and responsibilities of the US Agent are stated, which includes rather a communication role. It is also stated that the US Agent has no responsibilities related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E). This US Agent has to reside or maintain a business at USA and any changes can be updated electronically at the FURLS.

In the CFR 21Part 803 the requirements of a designated US Agent  which is responsible for reporting adverse events and submitting 510k  are stated and that the information about who is the designated US Agent has to be provided to FDA by letter as well as any change of this person. 
It is my understanding that this designated US Agent with reporting and submission responsibilities has not to be reside in the USA, that means that a person at the foreign manufacturer facility can be assigned as designated US Agent. 

Does this information and my understanding reflects the FDA requirements or I am missing something?

Any reliable reply is very much appreciated.

Thank you!

Kind regards,