Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hey everyone. I have a couple scenarios/questions regarding FDA establishment registration requirements (21 CFR Part 807) that I was hoping you could assist with. Any feedback is greatly appreciated.

• 1st scenario: A medical device is manufactured and sterilized at a facility (Facility 'A') in Europe, then sent to a facility (Facility 'B') in the US to be packaged, labelled, and readied for distribution.
• 2nd scenario: A medical device is manufactured and sterilized at a facility (Facility 'A') in Europe, then sent to another facility (Facility 'C') in the EU to be packaged, labelled, and readied for distribution.

Questions:

• In the 1st scenario, our thoughts were that as a domestic establishment, they need to be registered under FDA; however, given the broad definition of 'Manufacturer' and unique definition of 'Repackager/Relabeller', what should Facility 'B' register as?
• In the 2nd scenario, does Facility 'C' have registration obligations, and if so, what is the appropriate establishment type?

Thank you in advance for your time and feel free to let me know if you have questions.

There is a bit of complexity with facility registrations that can try to provide some comments.

In Scenario 1 you could have Facility B registered as the Manufacturer, Repackager/Relabeler, Importer, Distributor, or U.S. Agent or even a combination of those.  It depends on which facility A or B that you want to be viewed as the Manufacturer meaning the legal manufacturer of the medical device being distributed in the U.S.  Facility B could be the Manufacturer as the legal manufacturer and Facility A could also be the Manufacturer as the one that actually makes the device.  What you want to do is clearly define the relationships between Facility A and B to determine who is responsible for doing what activity.  As a foreign manufacturer there is also the need for a U.S. Agent and Importer that needs to be considered.

In Scenario 2 Facility C really may not need to register with FDA - it may depend on the level of packaging that the facility is doing.  I had one situation like this where a facility in Germany was the manufacturer and the packaging and sterilization took place in Italy.  We registered both facilities as Manufacturers because the facility in Italy was doing final testing, packaging, and responsible for the contract sterilizer.  We did not want the FDA showing up at the German facility and then learning about the Italy facility later on - they usually do not like that.  if the Italy facility was purely only packaging the device and then shipping back to Germany or shipping on to a contract sterilizer that Germany facility was responsible for, we probably would not have even registered the facility in Italy and only considered them a "supplier."

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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 26-Jun-2018 10:14
From: Anonymous Member
Subject: FDA Establishment Registrations

This message was posted by a user wishing to remain anonymous

Hey everyone. I have a couple scenarios/questions regarding FDA establishment registration requirements (21 CFR Part 807) that I was hoping you could assist with. Any feedback is greatly appreciated.

• 1st scenario: A medical device is manufactured and sterilized at a facility (Facility 'A') in Europe, then sent to a facility (Facility 'B') in the US to be packaged, labelled, and readied for distribution.
• 2nd scenario: A medical device is manufactured and sterilized at a facility (Facility 'A') in Europe, then sent to another facility (Facility 'C') in the EU to be packaged, labelled, and readied for distribution.

Questions:

• In the 1st scenario, our thoughts were that as a domestic establishment, they need to be registered under FDA; however, given the broad definition of 'Manufacturer' and unique definition of 'Repackager/Relabeller', what should Facility 'B' register as?
• In the 2nd scenario, does Facility 'C' have registration obligations, and if so, what is the appropriate establishment type?

Thank you in advance for your time and feel free to let me know if you have questions.

Also, don't forget about the potential need to register as a contract manufacturer if the medical devices leaves the first fitting the definition of a finished device. Do not be afraid to consult an FDA office if you have these questions. You can call direct or engage a consultant to ask these questions if you are concerned about questions, but it is important to get it right up front. Even as you read Richard's response, there are so many options that depend on the details. Good luck!

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Regards,
Mark Swanson, ASQ CBA, CMQ/OE, CQE ASQ, MBA
Becker MN
United States
------------------------------

Original Message:
Sent: 27-Jun-2018 05:29
From: Richard Vincins
Subject: FDA Establishment Registrations

There is a bit of complexity with facility registrations that can try to provide some comments.

In Scenario 1 you could have Facility B registered as the Manufacturer, Repackager/Relabeler, Importer, Distributor, or U.S. Agent or even a combination of those.  It depends on which facility A or B that you want to be viewed as the Manufacturer meaning the legal manufacturer of the medical device being distributed in the U.S.  Facility B could be the Manufacturer as the legal manufacturer and Facility A could also be the Manufacturer as the one that actually makes the device.  What you want to do is clearly define the relationships between Facility A and B to determine who is responsible for doing what activity.  As a foreign manufacturer there is also the need for a U.S. Agent and Importer that needs to be considered.

In Scenario 2 Facility C really may not need to register with FDA - it may depend on the level of packaging that the facility is doing.  I had one situation like this where a facility in Germany was the manufacturer and the packaging and sterilization took place in Italy.  We registered both facilities as Manufacturers because the facility in Italy was doing final testing, packaging, and responsible for the contract sterilizer.  We did not want the FDA showing up at the German facility and then learning about the Italy facility later on - they usually do not like that.  if the Italy facility was purely only packaging the device and then shipping back to Germany or shipping on to a contract sterilizer that Germany facility was responsible for, we probably would not have even registered the facility in Italy and only considered them a "supplier."

------------------------------
Richard Vincins RAC
Vice President Regulatory Affairs

Original Message:
Sent: 26-Jun-2018 10:14
From: Anonymous Member
Subject: FDA Establishment Registrations

This message was posted by a user wishing to remain anonymous

Hey everyone. I have a couple scenarios/questions regarding FDA establishment registration requirements (21 CFR Part 807) that I was hoping you could assist with. Any feedback is greatly appreciated.

• 1st scenario: A medical device is manufactured and sterilized at a facility (Facility 'A') in Europe, then sent to a facility (Facility 'B') in the US to be packaged, labelled, and readied for distribution.
• 2nd scenario: A medical device is manufactured and sterilized at a facility (Facility 'A') in Europe, then sent to another facility (Facility 'C') in the EU to be packaged, labelled, and readied for distribution.

Questions:

• In the 1st scenario, our thoughts were that as a domestic establishment, they need to be registered under FDA; however, given the broad definition of 'Manufacturer' and unique definition of 'Repackager/Relabeller', what should Facility 'B' register as?
• In the 2nd scenario, does Facility 'C' have registration obligations, and if so, what is the appropriate establishment type?

Thank you in advance for your time and feel free to let me know if you have questions.

I didn't know if you were aware of the following page, which I find very helpful.

Who Must Register, List and Pay the Fee

Fda		remove preview
Who Must Register, List and Pay the Fee Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.), including those that are imported for export only, are required to register annually with the FDA. View this on Fda >

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Corey Jaseph RAC
Director of Regulatory Affairs
South Jordan UT
United States
------------------------------

Original Message:
Sent: 26-Jun-2018 10:14
From: Anonymous Member
Subject: FDA Establishment Registrations

This message was posted by a user wishing to remain anonymous

Hey everyone. I have a couple scenarios/questions regarding FDA establishment registration requirements (21 CFR Part 807) that I was hoping you could assist with. Any feedback is greatly appreciated.

• 1st scenario: A medical device is manufactured and sterilized at a facility (Facility 'A') in Europe, then sent to a facility (Facility 'B') in the US to be packaged, labelled, and readied for distribution.
• 2nd scenario: A medical device is manufactured and sterilized at a facility (Facility 'A') in Europe, then sent to another facility (Facility 'C') in the EU to be packaged, labelled, and readied for distribution.

Questions:

• In the 1st scenario, our thoughts were that as a domestic establishment, they need to be registered under FDA; however, given the broad definition of 'Manufacturer' and unique definition of 'Repackager/Relabeller', what should Facility 'B' register as?
• In the 2nd scenario, does Facility 'C' have registration obligations, and if so, what is the appropriate establishment type?

Thank you in advance for your time and feel free to let me know if you have questions.