Shelf Life Testing of a Sterile Medical Device

M

MIREGMGR

#11
Once shelf-life is established, what is the regulatory and/or ISO expectation for monitoring shelf-life validity?
Accelerated-aging validation of shelf life must be backed up with real-time-aging validation. Once real-time-aging validation is accomplished, there is no need to "monitor" shelf life, since the validation necessarily was a comprehensive determination of the question.

If a validation weren't reliably determinative, it wouldn't be a validation.

This of course depends on the product and its packaging being consistent. Validation must be re-done from scratch if the product or its packaging change significantly for any reason, intentionally or not.
 
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J

JodiRaus

#12
Hallo All

can we declare a shelf life of sterile medical device for atleast six month without performing a shelf life testing. ?
FDA will give you a 6-month "gratis" on shelf life for a sterile medical device being studied under an IDE. However, I submitted our accelerated aging protocol in the IDE and disclosed our intent of labeling with a 24 month shelf life when testing was complete. My recommendation is to think very carefully before taking this approach. You will find that by the time you get IRB approval, contracts negotiated and site training complete you will have expired devices before they use the first one!
 
M

MIREGMGR

#13
FDA will give you a 6-month "gratis" on shelf life for a sterile medical device being studied under an IDE.
I hadn't heard this before...perhaps because historically we don't do any IDE work. It would seem that this would obviate the need for sterile barrier packaging and packaging-process validation if that six months was the full intended life...but I wasn't aware that there were any exceptions to that validation requirement. Can you point us to the relevant rule or guidance?
 

Michael Malis

Quite Involved in Discussions
#14
FDA will give you a 6-month "gratis" on shelf life for a sterile medical device being studied under an IDE. However, I submitted our accelerated aging protocol in the IDE and disclosed our intent of labeling with a 24 month shelf life when testing was complete. My recommendation is to think very carefully before taking this approach. You will find that by the time you get IRB approval, contracts negotiated and site training complete you will have expired devices before they use the first one!
Jodi,

To MIREGMGR point, accelerated-aging study must be backed up with real time validation.
FDA will allow you to go to the market with accelerated study only (6 months, 1 year or more) with the understanding that accelerated study will be followed by the real time study. When you submitted your protocol for "sterile medical device", sterility and life expectancy of your product is still in question. Therefore, you should outline in your protocol that over 2 year real time study there will be some points (1 year, 18 months, etc) at which you will extend the life of your device based on real time data available.

In other words, I plan to gradually extend the shelf life of the device as real time validation data allows me to do.

I hope this helps,
Mike
 
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mobylad

Starting to get Involved
#15
How much real time shelf life data do you need, to allow you to ship product. What expiry date can you put on your product? You say above that you need to have started the real time study, and have you accelerated study complete but if you have only conducted 6 months of the real time study, does this mean you can only label your product with a 6 month shelf life. In this scenario what is the point of accelerated data if the expiry date is decided by the amount of real time data?
 
M

MIREGMGR

#16
How much real time shelf life data do you need, to allow you to ship product. What expiry date can you put on your product? You say above that you need to have started the real time study, and have you accelerated study complete but if you have only conducted 6 months of the real time study, does this mean you can only label your product with a 6 month shelf life. In this scenario what is the point of accelerated data if the expiry date is decided by the amount of real time data?
You can initially ship based on completed accelerated-time study. So if you've done six-months-equivalent of accelerated-time, you can label with six months expiration...as long as you also have a real time aging test underway before you start marketing.

There is no explicit requirement for how far the real time study has gotten.

The accelerated study does not have to be "complete" out to your eventual goal. It can still be running, as long as it has been successful out to the expiration-life for which you will initially label.
 

Michael Malis

Quite Involved in Discussions
#17
How much real time shelf life data do you need, to allow you to ship product. What expiry date can you put on your product? You say above that you need to have started the real time study, and have you accelerated study complete but if you have only conducted 6 months of the real time study, does this mean you can only label your product with a 6 month shelf life. In this scenario what is the point of accelerated data if the expiry date is decided by the amount of real time data?
Mobylad,

If you completed accelerated study (2 years, for example), you can ship the product with 2 years expiration date as long as the real time data is "in -process". However, the real time data must be completed for the full time of intended expiration.

Hope this helps,
Mike
 

mobylad

Starting to get Involved
#18
Hi Mike,

I'm confused, your first sentence says that you can ship with 2 years
expiration data if you have 2 years worth of accelerated shelf life
data. *For arguments sake, say you get to 20 months real time data and
your testing fails..what happens then? *In the meantime you have
shipped product labelled with 24months!

cheers
Moby
 

mobylad

Starting to get Involved
#19
Thanks for your response, it was very clear.. but I find it difficult to believe that you can label you device (and ship it!) with an expiry date of 24 months based on accelerated stability data, if you only have 3 months of real time data.

What happens if your real time data fails after 18 months?
 
M

MIREGMGR

#20
If you've shipped product based on accelerated aging, and your follow-up real time evaluation fails at a time shorter than the labeled expiration of product you have distributed, you do a field action (recall or otherwise) for that product.

That's how it works.

Obviously no one would like that, so accelerated aging testing should be done in accordance with standards and with rigorous care to doing it right...not because that provides an excuse, but rather because many companies' experience is that accelerated aging per the standards with rigorous care is a valid way to evaluate the issue, and is consistent with the follow-up real time testing.

The history of accelerated aging has been gained based on relatively common types of devices and packaging systems. If there is some aspect of your product or packaging that is novel or otherwise gives rise to uncertainty as to whether that history might not apply, you might not want to use an accelerated aging approach until you've done a pre-study to establish that the approach you'll use will be valid.

Or, of course, you can just wait to market your product until you have real time data.
 
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