Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

​Hello,
I am working on a traditional 510(K) submission and current plans are to submit with 6-month (AA) shelf life data with real time and future AA testing at 13 and 25 month time points.
This will be the companies FIRST marketed device.
As far as I can find, there are no specific requirements stating that you must label a Device with a minimum shelf life - only that you have evidence to support device functionality, package integrity, etc for your labeled shelf life. 

My question is whether there is an expectation not specifically documented by FDA in which they require some sort of minimum shelf life or is it more a question of whether customers will be willing to purchase a product with a 6-month shelf life?

Thank you for your time.

Hello,

There is no minimum shelf life mandated by FDA or any regulation, it really depends on the device type.  The best approach is to benchmark if there is already an existing product type on the market for that shelf life period.  Also the shelf life should be considered for the length of time in inventory, shipping, and at customer site because maybe 6 months is too short.  Meaning by the time the customer gets the product there is only 2 months remaining, based on overturn of product.

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

Original Message:
Sent: 16-Jan-2020 14:26
From: Anonymous Member
Subject: Shelf Life

This message was posted by a user wishing to remain anonymous

​Hello,
I am working on a traditional 510(K) submission and current plans are to submit with 6-month (AA) shelf life data with real time and future AA testing at 13 and 25 month time points.
This will be the companies FIRST marketed device.
As far as I can find, there are no specific requirements stating that you must label a Device with a minimum shelf life - only that you have evidence to support device functionality, package integrity, etc for your labeled shelf life.

My question is whether there is an expectation not specifically documented by FDA in which they require some sort of minimum shelf life or is it more a question of whether customers will be willing to purchase a product with a 6-month shelf life?

Thank you for your time.

This message was posted by a user wishing to remain anonymous

Hello Richard,

Thank you for the input.  My argument to the team has long been that this decision (6-month shelf life) is more of a business risk not a regulatory risk.  We will be continuing with shelf life testing out to 2 years.  My concern in regards to FDA was that since our company currently does not have any product on the market, they may request that we provide real time data for the 6 month shelf life and the team is currently not planning on performing testing for RT at the 6 month time point.

Thanks again,
​
Original Message:
Sent: 17-Jan-2020 02:05
From: Richard Vincins
Subject: Shelf Life

Hello,

There is no minimum shelf life mandated by FDA or any regulation, it really depends on the device type.  The best approach is to benchmark if there is already an existing product type on the market for that shelf life period.  Also the shelf life should be considered for the length of time in inventory, shipping, and at customer site because maybe 6 months is too short.  Meaning by the time the customer gets the product there is only 2 months remaining, based on overturn of product.

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

Original Message:
Sent: 16-Jan-2020 14:26
From: Anonymous Member
Subject: Shelf Life

This message was posted by a user wishing to remain anonymous

​Hello,
I am working on a traditional 510(K) submission and current plans are to submit with 6-month (AA) shelf life data with real time and future AA testing at 13 and 25 month time points.
This will be the companies FIRST marketed device.
As far as I can find, there are no specific requirements stating that you must label a Device with a minimum shelf life - only that you have evidence to support device functionality, package integrity, etc for your labeled shelf life.

My question is whether there is an expectation not specifically documented by FDA in which they require some sort of minimum shelf life or is it more a question of whether customers will be willing to purchase a product with a 6-month shelf life?

Thank you for your time.

As I read the question, I wonder why you are asking about shelf life. In particular, you say, "there are no specific requirements stating that you must label a Device with a minimum shelf life". Many devices do not have a shelf life so there is no reason to state "some sort of minimum shelf life".

A device does not have a shelf life unless that is some performance characteristic that changes over time, typically in storage. The performance characteristic deteriorates until the device no longer meets the specification. The shelf life is set so the device does not deteriorate beyond its specs and actually has room for variability.

Do you have a clear understanding of what deteriorates, its mechanism, and the specification limit?

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 16-Jan-2020 14:26
From: Anonymous Member
Subject: Shelf Life

This message was posted by a user wishing to remain anonymous

​Hello,
I am working on a traditional 510(K) submission and current plans are to submit with 6-month (AA) shelf life data with real time and future AA testing at 13 and 25 month time points.
This will be the companies FIRST marketed device.
As far as I can find, there are no specific requirements stating that you must label a Device with a minimum shelf life - only that you have evidence to support device functionality, package integrity, etc for your labeled shelf life.

My question is whether there is an expectation not specifically documented by FDA in which they require some sort of minimum shelf life or is it more a question of whether customers will be willing to purchase a product with a 6-month shelf life?

Thank you for your time.