Accelerated Aging - Creating test samples - Implantable medical device Question

#1
I have a question about creating test samples to support an aging study for an implantable med device. We are looking to establish a 3 year shelf life for our product. We have some samples that have 18 months real time aging on them currently. Is it acceptable to "add" 18 months of aging to them using accelerated aging principles to get to 3 years? We will still have enough samples to real time age some units for an additional 18 months so we will real time data, but we need to get a jump on the schedule.

Is this an acceptable approach to conditioning aging samples? (18 mo RTA + 18 mo AA = 36 mo AA?) Has anyone used this or a similar strategy before for creating accelerated aging samples? If so, did you receive any push back from regulators?
 
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William55401

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#2
You need data in hand to defend your stated label claim. As you accumulate the longer term data, you can then revise your labeled shelf life. It is not grey. It is black and white.
 
#3
I'm not sure my question was understood correctly. We will have 3 years RTA data after 3 years (18 months from now). I'm trying to understand if it's acceptable to combine RTA and AA to create aged samples. My units have 18 months of RTA already. I want to perform and additional 18 months of aging using standard conditioning methodology. Can I then say the 18 months of actual time plus the 18 months of accelerated time will be equivalent to 36 months aging for testing purposes. We do plan to continue real time aging on some additional until they are 36 months old to support our claim.
 

monoj mon

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#4
Is this an acceptable approach to conditioning aging samples? (18 mo RTA + 18 mo AA = 36 mo AA?)
I have never heard of doing such combination. Since this is not a conventional way of claiming a shelf life, you may expect a push back.

Regarding suggestion of claiming shelf life, why don't you get fresh samples to conduct an 18 months of AA and submit your application with both of your 18 months AA and RTA (but continue RTA and AA on rest of the samples until 36 months). By that approach you can still claim your 36 months of shelf life, provided, you explain clearly (in your application) that your AA and RTA for 36 months is going on and you will adjust your shelf life claim on the labeling if you cannot get a 36 months of shelf life. I have done that before and have never received a single question from the regulators.

Remember, AA is just an assumption while RTA is the ultimate validation, mixing it up to claim a shelf life seems impractical to me. My personal thought is that if you now accelerate the age of your already 18 months old samples, the samples may not be able to withstand it and may eventually fail the testing. Because, there shall be a big difference in sample's condition if your pre-condition it for a limited time period (say for 24 hours) and if you pre-condition it for an extended time period (in your case, 18 months).
 

adir88

Starting to get Involved
#5
Combining 18 months of RT data with (only and additional) 18 months of AA data to get to 36 months shelf life is NOT a standard approach and it will most definitely not be accepted by regulatory bodies.

You have the following options:
1. Label the device with 18 months expiry date based on the the RT data you have available to date. You can then extend the shelf life as you get more data from future RT timepoints.
2. Label the device with the AA data you have available to date (if any) along with the 18 months RT data you have available to date. In this instance, you need to usually demonstrate that your AA data correlates to the RT data to date. Doing this analysis will provide more confidence of the extra shelf life you are claiming beyond (RT) 18 months. Doing a linear regression on RT and AA data to see when the product attribute intersects the acceptance criterion can also provide more confidence. I would recommend that you don't overshoot this extrapolation such that there is a significant lag between your AA and RT data and comes down to what you/your company is willing to accept as business risk. In my company we have a guideline to not have a greater than 12 months gap between RT and AA data. This is based on historical data and what our company feels comfortable with. For example, if we had AA data for 24 months and RT data for 10 months, we will not label the device with 24-month expiry date until the RT catches up.

Getting the shelf life validation right is really critical - if something goes wrong in the field because your determination was based on non-standard approaches, you WILL end up having to do some type of field safety corrective action.
 
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