Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi! could someone clarify which is the difference between shelf life, expiry date and expective/intended life time?
Thank you in advance!

This message was posted by a user wishing to remain anonymous

Hi

Shelf life is from when a device completes manufacture (including any sterilization) and the final point at which there is either no data or it is know the device itself (or the packaging) no longer meets specification. the expiry date is an indication of how long following completion of manufacture the shelf life is. 

'No longer meets specification' is either a failure of the device due to age related degradation or a failure of the packaging maintaining sterility or cleanliness as a result of age related degradation, as such the device no longer meets specification and should not be used. 

the lifetime is the period of time over which the device is expected to meet its intended purpose. for an implant, this may be years, for a scalpel it may be minutes. Typically, this is measured from the time the device is removed from its packaging and used within  a given procedure, or implanted etc. This is probably better expressed as lifetime-in-use. 

In the case of capital equipment or reusable devices, other metrics than time may be a more appropriate method to set lifetime. Number of uses, or inspection each time used with a clear specification of failure and thus end of life. 

Lifetime may sometimes be an expression of the shelf life plus lifetime-in-use, depending on how an organization defines it. Under European legislation, shelf life and lifetime are considered as separate elements with separate ER/GSPR.
Original Message:
Sent: 14-Mar-2022 08:07
From: Anonymous Member
Subject: shelf life vs expected/intended life vs expiry date

This message was posted by a user wishing to remain anonymous

Hi! could someone clarify which is the difference between shelf life, expiry date and expective/intended life time?
Thank you in advance!

If testing indicates shelf life to be 5 years but to increase sales the manufacturer lists shelf life at 1 year, is that permitted?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 14-Mar-2022 12:24
From: Anonymous Member
Subject: shelf life vs expected/intended life vs expiry date

This message was posted by a user wishing to remain anonymous

Hi

Shelf life is from when a device completes manufacture (including any sterilization) and the final point at which there is either no data or it is know the device itself (or the packaging) no longer meets specification. the expiry date is an indication of how long following completion of manufacture the shelf life is.

'No longer meets specification' is either a failure of the device due to age related degradation or a failure of the packaging maintaining sterility or cleanliness as a result of age related degradation, as such the device no longer meets specification and should not be used.

the lifetime is the period of time over which the device is expected to meet its intended purpose. for an implant, this may be years, for a scalpel it may be minutes. Typically, this is measured from the time the device is removed from its packaging and used within  a given procedure, or implanted etc. This is probably better expressed as lifetime-in-use.

In the case of capital equipment or reusable devices, other metrics than time may be a more appropriate method to set lifetime. Number of uses, or inspection each time used with a clear specification of failure and thus end of life.

Lifetime may sometimes be an expression of the shelf life plus lifetime-in-use, depending on how an organization defines it. Under European legislation, shelf life and lifetime are considered as separate elements with separate ER/GSPR.
Original Message:
Sent: 14-Mar-2022 08:07
From: Anonymous Member
Subject: shelf life vs expected/intended life vs expiry date

This message was posted by a user wishing to remain anonymous

Hi! could someone clarify which is the difference between shelf life, expiry date and expective/intended life time?
Thank you in advance!

Good day,

This is definitely a topic which has some type of mystery and different views, mostly because there is not a clear definition in regulations concerning the terms.  Excellent post above from Anon describing well the shelf life and use life of a product.  This can be a confusing topic because indeed shelf life, expiration date, life of product, useable life, service life, marketing life can mean all different things and might even be all the same.  I would like to add that shelf life and expiration date can also be different.  Expiration date can be more about the deterioration or non-functioning (no longer meets specification) of a product beyond a certain date.  As an example, shelf life date can be a sterile product where the packaging is tested but the product inside (maybe something metal) would not deteriorate itself over a long period of time.   Whereas, expiration date could be a product with a gel or liquid in it which would go bad or evaporate over time.  We recommend clearly defining for the company and even by product any terms of life of product because this can vary from device type to device type.

Ed, yes that is permittable and have seen companies do this.  There is nothing to say if the shelf life is tested out to 5 years, the company can put 2 or 3 years shelf life on the packaging.  In fact, usually need to test some point longer than the stated shelf life or expiration date inevitably when you have the customer call asking if it was ok to use the product outside the date on the package.  Though I think a "Best before" date on medical devices probably would not be accepted haha.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 14-Mar-2022 14:59
From: Ed Panek
Subject: shelf life vs expected/intended life vs expiry date

If testing indicates shelf life to be 5 years but to increase sales the manufacturer lists shelf life at 1 year, is that permitted?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 14-Mar-2022 12:24
From: Anonymous Member
Subject: shelf life vs expected/intended life vs expiry date

This message was posted by a user wishing to remain anonymous

Hi

Shelf life is from when a device completes manufacture (including any sterilization) and the final point at which there is either no data or it is know the device itself (or the packaging) no longer meets specification. the expiry date is an indication of how long following completion of manufacture the shelf life is.

'No longer meets specification' is either a failure of the device due to age related degradation or a failure of the packaging maintaining sterility or cleanliness as a result of age related degradation, as such the device no longer meets specification and should not be used.

the lifetime is the period of time over which the device is expected to meet its intended purpose. for an implant, this may be years, for a scalpel it may be minutes. Typically, this is measured from the time the device is removed from its packaging and used within  a given procedure, or implanted etc. This is probably better expressed as lifetime-in-use.

In the case of capital equipment or reusable devices, other metrics than time may be a more appropriate method to set lifetime. Number of uses, or inspection each time used with a clear specification of failure and thus end of life.

Lifetime may sometimes be an expression of the shelf life plus lifetime-in-use, depending on how an organization defines it. Under European legislation, shelf life and lifetime are considered as separate elements with separate ER/GSPR.
Original Message:
Sent: 14-Mar-2022 08:07
From: Anonymous Member
Subject: shelf life vs expected/intended life vs expiry date

This message was posted by a user wishing to remain anonymous

Hi! could someone clarify which is the difference between shelf life, expiry date and expective/intended life time?
Thank you in advance!

Hi Ed.

While I am not really a fan of this sort of thing, there is nothing in the regulation that prevents the company from making this sort of decision.  The regulation basically says you have to be able to prove that the product remains useful for its intended uses over the course of the product life cycle.  So as long as you can show that the product remains useful for at least the labeled shelf life then you are OK.  So if you have data showing the product is useful for 5 years and will continue to perform as expected for that entire time then you can label the product with a shelf life of up to 5 years.  If you as a business choose to try to increase sales by only labeling the product for use over a shelf life of 1 year, you have sufficient data based on your 5 year information to label the product as such and in my opinion would not receive any negative finding from the FDA or any other regulator or NB. 

But remember - competitors can sometimes can use this practice from your own company to bleed you of market share if you play this game too often or too well if they can show that they can provide the client with a shelf life of say 3 years.  It also can lead to some credibility issues in the marketplace if you have chosen this path and then miraculously when Competitor X comes into the market with 3 year shelf life you are able to extend your shelf life to 30 months or 3 years almost immediately.

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

Original Message:
Sent: 14-Mar-2022 14:59
From: Ed Panek
Subject: shelf life vs expected/intended life vs expiry date

If testing indicates shelf life to be 5 years but to increase sales the manufacturer lists shelf life at 1 year, is that permitted?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 14-Mar-2022 12:24
From: Anonymous Member
Subject: shelf life vs expected/intended life vs expiry date

This message was posted by a user wishing to remain anonymous

Hi

Shelf life is from when a device completes manufacture (including any sterilization) and the final point at which there is either no data or it is know the device itself (or the packaging) no longer meets specification. the expiry date is an indication of how long following completion of manufacture the shelf life is.

'No longer meets specification' is either a failure of the device due to age related degradation or a failure of the packaging maintaining sterility or cleanliness as a result of age related degradation, as such the device no longer meets specification and should not be used.

the lifetime is the period of time over which the device is expected to meet its intended purpose. for an implant, this may be years, for a scalpel it may be minutes. Typically, this is measured from the time the device is removed from its packaging and used within  a given procedure, or implanted etc. This is probably better expressed as lifetime-in-use.

In the case of capital equipment or reusable devices, other metrics than time may be a more appropriate method to set lifetime. Number of uses, or inspection each time used with a clear specification of failure and thus end of life.

Lifetime may sometimes be an expression of the shelf life plus lifetime-in-use, depending on how an organization defines it. Under European legislation, shelf life and lifetime are considered as separate elements with separate ER/GSPR.
Original Message:
Sent: 14-Mar-2022 08:07
From: Anonymous Member
Subject: shelf life vs expected/intended life vs expiry date

This message was posted by a user wishing to remain anonymous

Hi! could someone clarify which is the difference between shelf life, expiry date and expective/intended life time?
Thank you in advance!

Thanks, Victor. Just playing Devils Advocate here.

Imagine a scenario where a patient is critical and your device is likely to save them however because it appears the shelf life has expired your device is not used for treatment and inventory is searched for a product of yours with proper shelf life and during that delay, the patient suffers a reportable event due to the delay. Since the label provided an exclusion of usability that harmed the patient, would that be a concern?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 15-Mar-2022 09:50
From: Victor Mencarelli
Subject: shelf life vs expected/intended life vs expiry date

Hi Ed.

While I am not really a fan of this sort of thing, there is nothing in the regulation that prevents the company from making this sort of decision.  The regulation basically says you have to be able to prove that the product remains useful for its intended uses over the course of the product life cycle.  So as long as you can show that the product remains useful for at least the labeled shelf life then you are OK.  So if you have data showing the product is useful for 5 years and will continue to perform as expected for that entire time then you can label the product with a shelf life of up to 5 years.  If you as a business choose to try to increase sales by only labeling the product for use over a shelf life of 1 year, you have sufficient data based on your 5 year information to label the product as such and in my opinion would not receive any negative finding from the FDA or any other regulator or NB.

But remember - competitors can sometimes can use this practice from your own company to bleed you of market share if you play this game too often or too well if they can show that they can provide the client with a shelf life of say 3 years.  It also can lead to some credibility issues in the marketplace if you have chosen this path and then miraculously when Competitor X comes into the market with 3 year shelf life you are able to extend your shelf life to 30 months or 3 years almost immediately.

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

Original Message:
Sent: 14-Mar-2022 14:59
From: Ed Panek
Subject: shelf life vs expected/intended life vs expiry date

If testing indicates shelf life to be 5 years but to increase sales the manufacturer lists shelf life at 1 year, is that permitted?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 14-Mar-2022 12:24
From: Anonymous Member
Subject: shelf life vs expected/intended life vs expiry date

This message was posted by a user wishing to remain anonymous

Hi

Shelf life is from when a device completes manufacture (including any sterilization) and the final point at which there is either no data or it is know the device itself (or the packaging) no longer meets specification. the expiry date is an indication of how long following completion of manufacture the shelf life is.

'No longer meets specification' is either a failure of the device due to age related degradation or a failure of the packaging maintaining sterility or cleanliness as a result of age related degradation, as such the device no longer meets specification and should not be used.

the lifetime is the period of time over which the device is expected to meet its intended purpose. for an implant, this may be years, for a scalpel it may be minutes. Typically, this is measured from the time the device is removed from its packaging and used within  a given procedure, or implanted etc. This is probably better expressed as lifetime-in-use.

In the case of capital equipment or reusable devices, other metrics than time may be a more appropriate method to set lifetime. Number of uses, or inspection each time used with a clear specification of failure and thus end of life.

Lifetime may sometimes be an expression of the shelf life plus lifetime-in-use, depending on how an organization defines it. Under European legislation, shelf life and lifetime are considered as separate elements with separate ER/GSPR.
Original Message:
Sent: 14-Mar-2022 08:07
From: Anonymous Member
Subject: shelf life vs expected/intended life vs expiry date

This message was posted by a user wishing to remain anonymous

Hi! could someone clarify which is the difference between shelf life, expiry date and expective/intended life time?
Thank you in advance!

My opinion is not reportable and not an issue.  It might be a PR nightmare though.  To me use of the device outside of the shelf life would be a bigger issue for the user making that decision.  Again, I am asssuming that your product is labeled with shelf life for which you have adequate data to support the dating.  If you don't have adequate data then obviously there are more significant problems.  But if you are labeled correctly/appropriately then I don't see a true regulatory problem.

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

Original Message:
Sent: 15-Mar-2022 10:32
From: Ed Panek
Subject: shelf life vs expected/intended life vs expiry date

Thanks, Victor. Just playing Devils Advocate here.

Imagine a scenario where a patient is critical and your device is likely to save them however because it appears the shelf life has expired your device is not used for treatment and inventory is searched for a product of yours with proper shelf life and during that delay, the patient suffers a reportable event due to the delay. Since the label provided an exclusion of usability that harmed the patient, would that be a concern?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 15-Mar-2022 09:50
From: Victor Mencarelli
Subject: shelf life vs expected/intended life vs expiry date

Hi Ed.

While I am not really a fan of this sort of thing, there is nothing in the regulation that prevents the company from making this sort of decision.  The regulation basically says you have to be able to prove that the product remains useful for its intended uses over the course of the product life cycle.  So as long as you can show that the product remains useful for at least the labeled shelf life then you are OK.  So if you have data showing the product is useful for 5 years and will continue to perform as expected for that entire time then you can label the product with a shelf life of up to 5 years.  If you as a business choose to try to increase sales by only labeling the product for use over a shelf life of 1 year, you have sufficient data based on your 5 year information to label the product as such and in my opinion would not receive any negative finding from the FDA or any other regulator or NB.

But remember - competitors can sometimes can use this practice from your own company to bleed you of market share if you play this game too often or too well if they can show that they can provide the client with a shelf life of say 3 years.  It also can lead to some credibility issues in the marketplace if you have chosen this path and then miraculously when Competitor X comes into the market with 3 year shelf life you are able to extend your shelf life to 30 months or 3 years almost immediately.

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

Original Message:
Sent: 14-Mar-2022 14:59
From: Ed Panek
Subject: shelf life vs expected/intended life vs expiry date

If testing indicates shelf life to be 5 years but to increase sales the manufacturer lists shelf life at 1 year, is that permitted?

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani

Original Message:
Sent: 14-Mar-2022 12:24
From: Anonymous Member
Subject: shelf life vs expected/intended life vs expiry date

This message was posted by a user wishing to remain anonymous

Hi

Shelf life is from when a device completes manufacture (including any sterilization) and the final point at which there is either no data or it is know the device itself (or the packaging) no longer meets specification. the expiry date is an indication of how long following completion of manufacture the shelf life is.

'No longer meets specification' is either a failure of the device due to age related degradation or a failure of the packaging maintaining sterility or cleanliness as a result of age related degradation, as such the device no longer meets specification and should not be used.

the lifetime is the period of time over which the device is expected to meet its intended purpose. for an implant, this may be years, for a scalpel it may be minutes. Typically, this is measured from the time the device is removed from its packaging and used within  a given procedure, or implanted etc. This is probably better expressed as lifetime-in-use.

In the case of capital equipment or reusable devices, other metrics than time may be a more appropriate method to set lifetime. Number of uses, or inspection each time used with a clear specification of failure and thus end of life.

Lifetime may sometimes be an expression of the shelf life plus lifetime-in-use, depending on how an organization defines it. Under European legislation, shelf life and lifetime are considered as separate elements with separate ER/GSPR.
Original Message:
Sent: 14-Mar-2022 08:07
From: Anonymous Member
Subject: shelf life vs expected/intended life vs expiry date

This message was posted by a user wishing to remain anonymous

Hi! could someone clarify which is the difference between shelf life, expiry date and expective/intended life time?
Thank you in advance!

There was a good article in InCompliance Magazine covering this in the March 2022 issue:
https://digital.incompliancemag.com/issue/march-2022/expected-service-life-of-medical-electrical-equipment/

------------------------------
Wade Munsch
Regulatory Affairs Manager
Biotex, Inc.
Houston TX
United States
Website: www.biotexmedical.com
------------------------------

Original Message:
Sent: 14-Mar-2022 08:07
From: Anonymous Member
Subject: shelf life vs expected/intended life vs expiry date

This message was posted by a user wishing to remain anonymous

Hi! could someone clarify which is the difference between shelf life, expiry date and expective/intended life time?
Thank you in advance!