Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

Is an overseas recall reportable to FDA if it does not impact devices distributed in USA however the same models are marketed there.

Thanks

Simple answer as I understand the question is YES.  Any market action that could potentially impact or could pose similar impact to products marketed in the US would be reportable.  Even if a particular issue is limited to outside the US the fact is that if the same models (maybe not impacted by this specific problem) are sold in the US then the FDA wants to know about it.  You also should expect that if you are inspected by FDA after the notification that the inspection team will want to see your CAPA and your proof that you have implemented the commitments that you made in your CAPA and extended the investigation appropriately to the surrounding productions of the materials that could theoretically been impacted by the problem, regardless of where the products were ultimately sold.

------------------------------
Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
------------------------------

Original Message:
Sent: 12-Sep-2020 04:22
From: Anonymous Member
Subject: Reporting of overseas corrections /recalls

This message was posted by a user wishing to remain anonymous

Hi,

Is an overseas recall reportable to FDA if it does not impact devices distributed in USA however the same models are marketed there.

Thanks

Good day Anon,

In most cases the answer is yes because if you take a "corrective action" not to be confused with corrective action in the QMS system - but corrective action in the field meaning taking specific action to remove a volatile product from the market - you would notify all applicable regulatory agencies.  If you say are marketing a device in the United States, Canada, and Europe where the actual recall is done in Canada, e.g. the suspected products are only shipped to Canada, and a formal recall has been done there.  If the same product, say a different lot, is sold in U.S. it still would be advisable to at least notify U.S. FDA of the recall performed in Canada.  Of course this all goes toward a health hazard assessment performed for the actual product, that maybe the determination is made not to report in some countries or any country.  The scenario you do not want to be presented with is doing a number of recalls in Europe, none in U.S., and a FDA investigator shows up one day just "wanting to see what is going on" inspection.

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

Original Message:
Sent: 14-Sep-2020 13:52
From: Victor Mencarelli
Subject: Reporting of overseas corrections /recalls

Simple answer as I understand the question is YES.  Any market action that could potentially impact or could pose similar impact to products marketed in the US would be reportable.  Even if a particular issue is limited to outside the US the fact is that if the same models (maybe not impacted by this specific problem) are sold in the US then the FDA wants to know about it.  You also should expect that if you are inspected by FDA after the notification that the inspection team will want to see your CAPA and your proof that you have implemented the commitments that you made in your CAPA and extended the investigation appropriately to the surrounding productions of the materials that could theoretically been impacted by the problem, regardless of where the products were ultimately sold.

------------------------------
Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States

Original Message:
Sent: 12-Sep-2020 04:22
From: Anonymous Member
Subject: Reporting of overseas corrections /recalls

This message was posted by a user wishing to remain anonymous

Hi,

Is an overseas recall reportable to FDA if it does not impact devices distributed in USA however the same models are marketed there.

Thanks

This message was posted by a user wishing to remain anonymous

Hi all,

I have a similar but slightly different question:  Do regulatory agencies generally expect that overseas recalls for a product will be notified to them if they occur while the subject product is under review by the agency (i.e. not yet authorized for marketing in that country)?

Thank you.
Original Message:
Sent: 15-Sep-2020 03:53
From: Richard Vincins
Subject: Reporting of overseas corrections /recalls

Good day Anon,

In most cases the answer is yes because if you take a "corrective action" not to be confused with corrective action in the QMS system - but corrective action in the field meaning taking specific action to remove a volatile product from the market - you would notify all applicable regulatory agencies.  If you say are marketing a device in the United States, Canada, and Europe where the actual recall is done in Canada, e.g. the suspected products are only shipped to Canada, and a formal recall has been done there.  If the same product, say a different lot, is sold in U.S. it still would be advisable to at least notify U.S. FDA of the recall performed in Canada.  Of course this all goes toward a health hazard assessment performed for the actual product, that maybe the determination is made not to report in some countries or any country.  The scenario you do not want to be presented with is doing a number of recalls in Europe, none in U.S., and a FDA investigator shows up one day just "wanting to see what is going on" inspection.

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

Original Message:
Sent: 14-Sep-2020 13:52
From: Victor Mencarelli
Subject: Reporting of overseas corrections /recalls

Simple answer as I understand the question is YES.  Any market action that could potentially impact or could pose similar impact to products marketed in the US would be reportable.  Even if a particular issue is limited to outside the US the fact is that if the same models (maybe not impacted by this specific problem) are sold in the US then the FDA wants to know about it.  You also should expect that if you are inspected by FDA after the notification that the inspection team will want to see your CAPA and your proof that you have implemented the commitments that you made in your CAPA and extended the investigation appropriately to the surrounding productions of the materials that could theoretically been impacted by the problem, regardless of where the products were ultimately sold.

------------------------------
Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States

Original Message:
Sent: 12-Sep-2020 04:22
From: Anonymous Member
Subject: Reporting of overseas corrections /recalls

This message was posted by a user wishing to remain anonymous

Hi,

Is an overseas recall reportable to FDA if it does not impact devices distributed in USA however the same models are marketed there.

Thanks

I have never experienced such a situation but I would think that as part of the application process you have provided information on the product "real world" safety (things like an overview of the number of units sold in other countries, maybe some information around the number and types of adverse events, etc.) along with information on the product's indications and prescription information or use information for the healthcare providers.  If there is anything in these documents that would speak to the use or the safety of the product which also would potentially link to the fact that the product is now being recalled in jurisdiction X, then I would suspect that the regulators would want to know about that in the country where it is still under application review.  Like Spyros if nothing else it is transparency for the regulator to feel more comfortable with the applicant that the applicant is not holding anything back from the regulator for their review.

Not only that, but also just remember - many of these regulators are in contact with each other on a potentially regular basis...who would you rather the reviewer here of the recall/removal/etc. from - you or their friend in another country?  So while I am not sure if this is actually "required" in the regulations of any particular jurisdiction, I would suggest that holding the information back from the regulatory agency reviewing your new/pending application is likely to at least raise some eyebrows.

------------------------------
Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
------------------------------

Original Message:
Sent: 15-Sep-2020 20:06
From: Anonymous Member
Subject: Reporting of overseas corrections /recalls

This message was posted by a user wishing to remain anonymous

Hi all,

I have a similar but slightly different question:  Do regulatory agencies generally expect that overseas recalls for a product will be notified to them if they occur while the subject product is under review by the agency (i.e. not yet authorized for marketing in that country)?

Thank you.
Original Message:
Sent: 15-Sep-2020 03:53
From: Richard Vincins
Subject: Reporting of overseas corrections /recalls

Good day Anon,

In most cases the answer is yes because if you take a "corrective action" not to be confused with corrective action in the QMS system - but corrective action in the field meaning taking specific action to remove a volatile product from the market - you would notify all applicable regulatory agencies.  If you say are marketing a device in the United States, Canada, and Europe where the actual recall is done in Canada, e.g. the suspected products are only shipped to Canada, and a formal recall has been done there.  If the same product, say a different lot, is sold in U.S. it still would be advisable to at least notify U.S. FDA of the recall performed in Canada.  Of course this all goes toward a health hazard assessment performed for the actual product, that maybe the determination is made not to report in some countries or any country.  The scenario you do not want to be presented with is doing a number of recalls in Europe, none in U.S., and a FDA investigator shows up one day just "wanting to see what is going on" inspection.

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

Original Message:
Sent: 14-Sep-2020 13:52
From: Victor Mencarelli
Subject: Reporting of overseas corrections /recalls

Simple answer as I understand the question is YES.  Any market action that could potentially impact or could pose similar impact to products marketed in the US would be reportable.  Even if a particular issue is limited to outside the US the fact is that if the same models (maybe not impacted by this specific problem) are sold in the US then the FDA wants to know about it.  You also should expect that if you are inspected by FDA after the notification that the inspection team will want to see your CAPA and your proof that you have implemented the commitments that you made in your CAPA and extended the investigation appropriately to the surrounding productions of the materials that could theoretically been impacted by the problem, regardless of where the products were ultimately sold.

------------------------------
Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States

Original Message:
Sent: 12-Sep-2020 04:22
From: Anonymous Member
Subject: Reporting of overseas corrections /recalls

This message was posted by a user wishing to remain anonymous

Hi,

Is an overseas recall reportable to FDA if it does not impact devices distributed in USA however the same models are marketed there.

Thanks

Generally yes. In the US, for instance, there is an expectation (captured more explicitly in a 510(k) truthful and accurate statement) that you will disclose all "relevant" information. It is pretty hard to argue that a recall on the same product isn't relevant, or at least potentially relevant. Many other geographies have similar requirements. If you feel it really isn't relevant, it is better to tell them and then explain why, than to get accused of "hiding" it later.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 15-Sep-2020 20:06
From: Anonymous Member
Subject: Reporting of overseas corrections /recalls

This message was posted by a user wishing to remain anonymous

Hi all,

I have a similar but slightly different question:  Do regulatory agencies generally expect that overseas recalls for a product will be notified to them if they occur while the subject product is under review by the agency (i.e. not yet authorized for marketing in that country)?

Thank you.
Original Message:
Sent: 15-Sep-2020 03:53
From: Richard Vincins
Subject: Reporting of overseas corrections /recalls

Good day Anon,

In most cases the answer is yes because if you take a "corrective action" not to be confused with corrective action in the QMS system - but corrective action in the field meaning taking specific action to remove a volatile product from the market - you would notify all applicable regulatory agencies.  If you say are marketing a device in the United States, Canada, and Europe where the actual recall is done in Canada, e.g. the suspected products are only shipped to Canada, and a formal recall has been done there.  If the same product, say a different lot, is sold in U.S. it still would be advisable to at least notify U.S. FDA of the recall performed in Canada.  Of course this all goes toward a health hazard assessment performed for the actual product, that maybe the determination is made not to report in some countries or any country.  The scenario you do not want to be presented with is doing a number of recalls in Europe, none in U.S., and a FDA investigator shows up one day just "wanting to see what is going on" inspection.

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

Original Message:
Sent: 14-Sep-2020 13:52
From: Victor Mencarelli
Subject: Reporting of overseas corrections /recalls

Simple answer as I understand the question is YES.  Any market action that could potentially impact or could pose similar impact to products marketed in the US would be reportable.  Even if a particular issue is limited to outside the US the fact is that if the same models (maybe not impacted by this specific problem) are sold in the US then the FDA wants to know about it.  You also should expect that if you are inspected by FDA after the notification that the inspection team will want to see your CAPA and your proof that you have implemented the commitments that you made in your CAPA and extended the investigation appropriately to the surrounding productions of the materials that could theoretically been impacted by the problem, regardless of where the products were ultimately sold.

------------------------------
Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States

Original Message:
Sent: 12-Sep-2020 04:22
From: Anonymous Member
Subject: Reporting of overseas corrections /recalls

This message was posted by a user wishing to remain anonymous

Hi,

Is an overseas recall reportable to FDA if it does not impact devices distributed in USA however the same models are marketed there.

Thanks

I am with Richard and Victor on that.

You may think It may affect (for some reason) only a market, but without an investigation, you cannot be sure that it will not affect also the other markets.
Probably the authorities, which have the whole picture, may see something that is obvious for them, but not familiar to you.

As regards the other question, I am not sure that you are obliged to report any incidents to a non approved product, but it is a matter of good will. They will probably figure it out any way at some point.

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 12-Sep-2020 04:22
From: Anonymous Member
Subject: Reporting of overseas corrections /recalls

This message was posted by a user wishing to remain anonymous

Hi,

Is an overseas recall reportable to FDA if it does not impact devices distributed in USA however the same models are marketed there.

Thanks