We are currently in the process of withdrawing our radiation-emitting product (a built-in class 1 laser product)
that is currently marketed in the U.S.
Hello all,
Hope everyone is in good health.
We are currently in the process of withdrawing our radiation-emitting product (a built-in class 1 laser product) that is currently marketed in the U.S.
The reason of withdrawal is due to unsatisfactory sales performance, and as such we have decided to no longer export them to U.S.
In light of this situation, is a Final Report required to be submitted to FDA for this notification?
I have searched through the FDA website, and the entries that I have found for market withdrawal refers to product defect and violation of certain natures, among others, all of which are totally different from our current situation.
If a Final Report is required to be submitted to FDA for this notification, could anyone please help assist in answering the following:
1. Is there a standard template for such Final Report? If there is, where could I find one.
2. If there is no standard template for the Final Report, what kind of information that must be included in the Final Report.
3. Where (which section of FDA) we should submit the Final Report.
4. Are there any other supplementary documents/materials required for the submission of the Final Report.
Thank you for your attention and any help is much appreciated.
that is currently marketed in the U.S.
Hello all,
Hope everyone is in good health.
We are currently in the process of withdrawing our radiation-emitting product (a built-in class 1 laser product) that is currently marketed in the U.S.
The reason of withdrawal is due to unsatisfactory sales performance, and as such we have decided to no longer export them to U.S.
In light of this situation, is a Final Report required to be submitted to FDA for this notification?
I have searched through the FDA website, and the entries that I have found for market withdrawal refers to product defect and violation of certain natures, among others, all of which are totally different from our current situation.
If a Final Report is required to be submitted to FDA for this notification, could anyone please help assist in answering the following:
1. Is there a standard template for such Final Report? If there is, where could I find one.
2. If there is no standard template for the Final Report, what kind of information that must be included in the Final Report.
3. Where (which section of FDA) we should submit the Final Report.
4. Are there any other supplementary documents/materials required for the submission of the Final Report.
Thank you for your attention and any help is much appreciated.
