Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear  all ,

Please just a few question on implantable Screw label sold non sterile.
Is it mandatory to put on the label an expiry date. and expiry date ?

Thank you in advance for your response.

Rgds,

Hi,

Labeling regulations for FDA are under CFR 801.  Generally if the implantable screws are nonsterile and there is no defined device life (i.e. they are metal, not absorbable type screws and won't deteriorate when the package sits on the shelf), then the manufacturer documents the device life information in the DHF and would not put any expiration date on the screw.  It would be desired to clearly identify the screws as being nonsterile and required to include the other regulated label information (device identifiers).  

Kind regards,

------------------------------
Alyssa Thomas RAC
Principal Consultant
Beaverton OR
United States
------------------------------

Original Message:
Sent: 02-Feb-2021 16:34
From: Anonymous Member
Subject: Expiry date for implantable Screw non sterile on the label

This message was posted by a user wishing to remain anonymous

Dear  all ,

Please just a few question on implantable Screw label sold non sterile.
Is it mandatory to put on the label an expiry date. and expiry date ?

Thank you in advance for your response.

Rgds,

Hello Anon,

It is generally accepted if there is no shelf life, no expiration date, or no end of life time period for a device, then an expiry date is not expected on the device labelling.  Products which are sterile typically have a shelf life where the packaging and sterilisation integrity has been validated.  Products which are non-sterile typically would have no shelf life date or expiry unless there was a component or part of the device which deteriorates over time, thus requiring an expiration date.  It would be recommended in the product specification, Design History File (DHF) records, or technical documentation clearly defining the life of the device and any associated shelf life/expiration date including reasons for not having such a date.  If there is no expiration date/shelf life you do not want to get into a corner by putting something which is not required or needed, especially because you would need the data to support the expiration date/shelf life.

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

Original Message:
Sent: 03-Feb-2021 01:42
From: Alyssa Thomas
Subject: Expiry date for implantable Screw non sterile on the label

Hi,

Labeling regulations for FDA are under CFR 801.  Generally if the implantable screws are nonsterile and there is no defined device life (i.e. they are metal, not absorbable type screws and won't deteriorate when the package sits on the shelf), then the manufacturer documents the device life information in the DHF and would not put any expiration date on the screw.  It would be desired to clearly identify the screws as being nonsterile and required to include the other regulated label information (device identifiers).

Kind regards,

------------------------------
Alyssa Thomas RAC
Principal Consultant
Beaverton OR
United States

Original Message:
Sent: 02-Feb-2021 16:34
From: Anonymous Member
Subject: Expiry date for implantable Screw non sterile on the label

This message was posted by a user wishing to remain anonymous

Dear  all ,

Please just a few question on implantable Screw label sold non sterile.
Is it mandatory to put on the label an expiry date. and expiry date ?

Thank you in advance for your response.

Rgds,

This message was posted by a user wishing to remain anonymous

Thank you so much Richard and Alyssa.
Original Message:
Sent: 03-Feb-2021 02:50
From: Richard Vincins
Subject: Expiry date for implantable Screw non sterile on the label

Hello Anon,

It is generally accepted if there is no shelf life, no expiration date, or no end of life time period for a device, then an expiry date is not expected on the device labelling.  Products which are sterile typically have a shelf life where the packaging and sterilisation integrity has been validated.  Products which are non-sterile typically would have no shelf life date or expiry unless there was a component or part of the device which deteriorates over time, thus requiring an expiration date.  It would be recommended in the product specification, Design History File (DHF) records, or technical documentation clearly defining the life of the device and any associated shelf life/expiration date including reasons for not having such a date.  If there is no expiration date/shelf life you do not want to get into a corner by putting something which is not required or needed, especially because you would need the data to support the expiration date/shelf life.

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

Original Message:
Sent: 03-Feb-2021 01:42
From: Alyssa Thomas
Subject: Expiry date for implantable Screw non sterile on the label

Hi,

Labeling regulations for FDA are under CFR 801.  Generally if the implantable screws are nonsterile and there is no defined device life (i.e. they are metal, not absorbable type screws and won't deteriorate when the package sits on the shelf), then the manufacturer documents the device life information in the DHF and would not put any expiration date on the screw.  It would be desired to clearly identify the screws as being nonsterile and required to include the other regulated label information (device identifiers).

Kind regards,

------------------------------
Alyssa Thomas RAC
Principal Consultant
Beaverton OR
United States

Original Message:
Sent: 02-Feb-2021 16:34
From: Anonymous Member
Subject: Expiry date for implantable Screw non sterile on the label

This message was posted by a user wishing to remain anonymous

Dear  all ,

Please just a few question on implantable Screw label sold non sterile.
Is it mandatory to put on the label an expiry date. and expiry date ?

Thank you in advance for your response.

Rgds,