What is different between Field Safety Notice and Advisory Notice in U.S and EU?

[Adisuan]

Hi Everyone,

I would like to know what's different between field safety notice and advisory notice in U.S. and EU because I have reviewed it and try to study it but it some point unclear.

In my understand field safety notice would like to action to make once medical device product error or cannot using and it will send to AR or National Competent Authority but advisory notice would like to action to our customer and agent who are buying our medical device product, right???

Could you please help to explain, sharing knowledge and sharing the sample of field safety notice and advisory notice procedure to me.

Thank you very much
Adisuan

 

[indubioush]

Per the EU MDR: ‘field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action;
and
‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market;

Per ISO 13485:
advisory notice: notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information or to advise on action to be taken in the:
— use of a medical device,
— modification of a medical device,
— return of the medical device to the organization that supplied it, or
— destruction of a medical device

Per US FDA 21CFR806: Correction means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location.
and
Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.

 

[Adisuan]

Per the EU MDR: ‘field safety notice’ means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action;
and
‘field safety corrective action’ means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market;

Per ISO 13485:
advisory notice: notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information or to advise on action to be taken in the:
— use of a medical device,
— modification of a medical device,
— return of the medical device to the organization that supplied it, or
— destruction of a medical device

Per US FDA 21CFR806: Correction means the repair, modification, adjustment, relabeling, destruction, or inspection (including patient monitoring) of a device without its physical removal from its point of use to some other location.
and
Removal means the physical removal of a device from its point of use to some other location for repair, modification, adjustment, relabeling, destruction, or inspection.

Thank you very much for your explain. It is make me clearly, so do you have a sample of field safety notice and advisory notice procedure?

 

[indubioush]

Sorry. I don't have one I am able to share; however, if you ask further questions here, I'm sure you will be able to get a lot of help.

 

[Adisuan]

Sorry. I don't have one I am able to share; however, if you ask further questions here, I'm sure you will be able to get a lot of help.

Thank you for your kindly support.
I will using you explain for make procedure.

 

[monoj mon]

so do you have a sample of field safety notice

For sample Field Safety Notice, you can go to databases like this and go through other's FSNs to check what are the information provided.

BfArM - Field corrective actions

 

[monoj mon]

Just remember, depending on which country you are sending the FSNs, you may need to translate the exact content into multiple languages. FSNs are sent to the customers whereas FSCA+FSN are sent to the authorities. I have attached a template for FSCA downloaded from this link. For a general FSN template visit this link to download a copy. For your convenience, I already have attached it too.

 

[Adisuan]

Thank you very much! Monoj Mon.
I will see your suggestion website and file as attached for my reference.