Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi All,

I would like to export a device to a country that does not any regulatory requirements for the device.  Could use some guidance on regulatory requirements.

Background:
The device is classified as a component that will be used by an overseas manufacturer to produce the finished device.

The device family has a 510(k).  This material is slightly different in composition than the material submitted for use in the 510(k).  The different composition does significantly alter the properties, intended use, etc...

With a bit of digging, I have found two avenues on the regulatory side for exporting the material:

1.  Based on the 510(k) decision tree for materiel changes it appears that we can use the produce name on the Certificate to Foreign Government providing we can demonstrate the risk and bio assessment do not identify any new or increased concerns and document with a letter to file.
2.  I also located on the FDA website the following URL: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ImportingandExportingDevices/ExportingMedicalDevices/ucm346617.htm  Exporting Unapproved Medical Devices.

I am not sure if this material would be classified as an Unapproved Medical Device due to item 1 above. 
The material can be used to produce products in the same family.  Although, this specific material is not used used to manufacturer a product sold by our organization in the United States.
The material is used by other organizations in the US to produce a component similar to the one mentioned above.

Any thoughts/ides other avenues that can be used to export the product that come to mind would be greatly appreciated.

Thanks

Original Message------

This message was posted by a user wishing to remain anonymous

Hi All,

I would like to export a device to a country that does not any regulatory requirements for the device.  Could use some guidance on regulatory requirements.

Background:
The device is classified as a component that will be used by an overseas manufacturer to produce the finished device.

The device family has a 510(k).  This material is slightly different in composition than the material submitted for use in the 510(k).  The different composition does significantly alter the properties, intended use, etc...

With a bit of digging, I have found two avenues on the regulatory side for exporting the material:

1.  Based on the 510(k) decision tree for materiel changes it appears that we can use the produce name on the Certificate to Foreign Government providing we can demonstrate the risk and bio assessment do not identify any new or increased concerns and document with a letter to file.
2.  I also located on the FDA website the following URL: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ImportingandExportingDevices/ExportingMedicalDevices/ucm346617.htm  Exporting Unapproved Medical Devices.

I am not sure if this material would be classified as an Unapproved Medical Device due to item 1 above. 
The material can be used to produce products in the same family.  Although, this specific material is not used used to manufacturer a product sold by our organization in the United States.
The material is used by other organizations in the US to produce a component similar to the one mentioned above.

Any thoughts/ides other avenues that can be used to export the product that come to mind would be greatly appreciated.

Thanks

This message was posted by a user wishing to remain anonymous

Can the product be labeled without a product name (no logo) or would the labeling, SDS, export shipping docs, etc... need to have the product name of the similar product?  Other?
Original Message:
Sent: 19-Apr-2019 07:42
From: Lee Leichter
Subject: Class II Device for Export

It would seem to me that unless you are looking for some sort of certificate from FDA, that these are not finished medical devices and are to be labeled and exported as components for further manufacture.  Also, if this is acceptable in the country to which you are exporting (not a finished device) I do not believe you have any other obligations under US regulations.

 

If you need a certificate, you can get a "Certificate of Exportability" under Section 801(e)(1)) if you have a "reasonable belief" that the FDA, if asked, would issue a 510(k) authorization for the device and the device is (i) be in accordance with the specifications of the foreign purchaser, (ii) labeled on the outside of the shipping package "intended for export," (iii) not in conflict with the laws of the importing country, and (iv) not sold or marketed for sale in United States.

 

Lee Leichter

President

P/L Biomedical

10882 Stonington Avenue

Fort Myers, FL 33913 USA

Office: +1-239-244-1448

Cell: +1-239-994-6488

Email: leichter@plbiomedical.com

 

Original Message------

This message was posted by a user wishing to remain anonymous

Hi All,

I would like to export a device to a country that does not any regulatory requirements for the device.  Could use some guidance on regulatory requirements.

Background:
The device is classified as a component that will be used by an overseas manufacturer to produce the finished device.

The device family has a 510(k).  This material is slightly different in composition than the material submitted for use in the 510(k).  The different composition does significantly alter the properties, intended use, etc...

With a bit of digging, I have found two avenues on the regulatory side for exporting the material:

1.  Based on the 510(k) decision tree for materiel changes it appears that we can use the produce name on the Certificate to Foreign Government providing we can demonstrate the risk and bio assessment do not identify any new or increased concerns and document with a letter to file.
2.  I also located on the FDA website the following URL: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ImportingandExportingDevices/ExportingMedicalDevices/ucm346617.htm  Exporting Unapproved Medical Devices.

I am not sure if this material would be classified as an Unapproved Medical Device due to item 1 above.
The material can be used to produce products in the same family.  Although, this specific material is not used used to manufacturer a product sold by our organization in the United States.
The material is used by other organizations in the US to produce a component similar to the one mentioned above.

Any thoughts/ides other avenues that can be used to export the product that come to mind would be greatly appreciated.

Thanks

If it is a component for further manufacturing and not a finished device, it does not need to be labeled, not need a product name

Sent from my iPhone


Original Message------

This message was posted by a user wishing to remain anonymous

Can the product be labeled without a product name (no logo) or would the labeling, SDS, export shipping docs, etc... need to have the product name of the similar product?  Other?

Thank you Lee.  Greatly appreciated.

------------------------------
Craig Jolicoeur CMQ/OE, CQE
Quality and Regulatory Manager
San Marcos CA
United States
------------------------------

Original Message:
Sent: 21-Apr-2019 17:43
From: Lee Leichter
Subject: Class II Device for Export

If it is a component for further manufacturing and not a finished device, it does not need to be labeled, not need a product name

Sent from my iPhone


Original Message------

This message was posted by a user wishing to remain anonymous

Can the product be labeled without a product name (no logo) or would the labeling, SDS, export shipping docs, etc... need to have the product name of the similar product?  Other?