Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All,

I have a finished device (dental zirconia disc) that will be further processed (to produce dental crowns and bridges) in a country that has no regulatory requirements for the device.
The device has a 510(k).  The 510(k) submission was for a slightly different material composition.  The components of the material are almost identical with a slight change in one of the materials components.  The existing risk analysis used for the 510(k) is applicable, the bio compatibility test reports for the original material are applicable, and the material has properties that are so similar to the original material, it could be considered identical to the properties of the material listed on the 510(k).

Can I export this material to a country with no regulatory requirements with the same product name, labeling, etc... as the product listed with the FDA? Other?

Thanks for any advice.

​You should have a process in place for making these types of decisions - Deciding when to submit a new 510(k).  The FDA provides all kinds of guidance on this.  I would use FDA's decision tree to base your rationale.  If you reasoning is sound and justifiable, you should document this in a Letter to File.  This new device can be Listed with the FDA based on the previous 510(k) and marketed wherever it is needed as a cleared device.

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States
------------------------------

Original Message:
Sent: 30-Apr-2019 01:02
From: Anonymous Member
Subject: Finished Device for Export - Material Change

This message was posted by a user wishing to remain anonymous

Hi All,

I have a finished device (dental zirconia disc) that will be further processed (to produce dental crowns and bridges) in a country that has no regulatory requirements for the device.
The device has a 510(k).  The 510(k) submission was for a slightly different material composition.  The components of the material are almost identical with a slight change in one of the materials components.  The existing risk analysis used for the 510(k) is applicable, the bio compatibility test reports for the original material are applicable, and the material has properties that are so similar to the original material, it could be considered identical to the properties of the material listed on the 510(k).

Can I export this material to a country with no regulatory requirements with the same product name, labeling, etc... as the product listed with the FDA? Other?

Thanks for any advice.

This message was posted by a user wishing to remain anonymous

Thanks Al,
​
You should have a process in place for making these types of decisions - Deciding when to submit a new 510(k).
        We do!  This is a one-off.

If I sold this as a no-logo device, would I still need to meet the 510(k) requirements for a material change?
I am assuming I would (not sure) since the finished device is manufactured in the US.
Original Message:
Sent: 01-May-2019 10:07
From: Al Van Houdt
Subject: Finished Device for Export - Material Change

​You should have a process in place for making these types of decisions - Deciding when to submit a new 510(k).  The FDA provides all kinds of guidance on this.  I would use FDA's decision tree to base your rationale.  If you reasoning is sound and justifiable, you should document this in a Letter to File.  This new device can be Listed with the FDA based on the previous 510(k) and marketed wherever it is needed as a cleared device.

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States

Original Message:
Sent: 30-Apr-2019 01:02
From: Anonymous Member
Subject: Finished Device for Export - Material Change

This message was posted by a user wishing to remain anonymous

Hi All,

I have a finished device (dental zirconia disc) that will be further processed (to produce dental crowns and bridges) in a country that has no regulatory requirements for the device.
The device has a 510(k).  The 510(k) submission was for a slightly different material composition.  The components of the material are almost identical with a slight change in one of the materials components.  The existing risk analysis used for the 510(k) is applicable, the bio compatibility test reports for the original material are applicable, and the material has properties that are so similar to the original material, it could be considered identical to the properties of the material listed on the 510(k).

Can I export this material to a country with no regulatory requirements with the same product name, labeling, etc... as the product listed with the FDA? Other?

Thanks for any advice.

​If you manufacture and sell a finished medical device, you must go through the process of ensuring the device can be cleared via LTF or needs a new 510(k).  If this is just a one-off and sold outside the USA, I propose you simply label it as "Export Only" and then no clearance is needed.  You will still need to list the device.

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States
------------------------------

Original Message:
Sent: 01-May-2019 13:32
From: Anonymous Member
Subject: Finished Device for Export - Material Change

This message was posted by a user wishing to remain anonymous

Thanks Al,
​
You should have a process in place for making these types of decisions - Deciding when to submit a new 510(k).
        We do!  This is a one-off.

If I sold this as a no-logo device, would I still need to meet the 510(k) requirements for a material change?
I am assuming I would (not sure) since the finished device is manufactured in the US.
Original Message:
Sent: 01-May-2019 10:07
From: Al Van Houdt
Subject: Finished Device for Export - Material Change

​You should have a process in place for making these types of decisions - Deciding when to submit a new 510(k).  The FDA provides all kinds of guidance on this.  I would use FDA's decision tree to base your rationale.  If you reasoning is sound and justifiable, you should document this in a Letter to File.  This new device can be Listed with the FDA based on the previous 510(k) and marketed wherever it is needed as a cleared device.

------------------------------
Al Van Houdt RAC
Sr. Mgr. Regulatory Affairs & Compliance
Snoqualmie WA
United States

Original Message:
Sent: 30-Apr-2019 01:02
From: Anonymous Member
Subject: Finished Device for Export - Material Change

This message was posted by a user wishing to remain anonymous

Hi All,

I have a finished device (dental zirconia disc) that will be further processed (to produce dental crowns and bridges) in a country that has no regulatory requirements for the device.
The device has a 510(k).  The 510(k) submission was for a slightly different material composition.  The components of the material are almost identical with a slight change in one of the materials components.  The existing risk analysis used for the 510(k) is applicable, the bio compatibility test reports for the original material are applicable, and the material has properties that are so similar to the original material, it could be considered identical to the properties of the material listed on the 510(k).

Can I export this material to a country with no regulatory requirements with the same product name, labeling, etc... as the product listed with the FDA? Other?

Thanks for any advice.