Accelerated Aging Testing Question

N

NicoleinFlorida

Hello all,

I have a question about accelerated aging test.

I am working on 510k for the first device of our company. The device is similar to surgical clips, which is composed of ABS,PC, pure titanium and stainless steal, etc. FDA asked for additional information about the accelerated aging test. Specifically, FDA required to provide scientific evidence that the material used in our device decomposed with similar mechanisms at elevated and standard temperature.

Right now, we cannot provide real-time aging test now to valid the accelerated aging.

Could you provide me some suggestions to solve this problem?

Thank you.:thanx:

Nicole
 

TWA - not the airline

Trusted Information Resource
Re: Question about Accelerated Aging

Hi Nicole, does "decompose" mean it is bioresorbable or (something similar) in-vivo? Or do you use some rather uncommon materials?

In my experience as long as the device consists of the typical polymers and metals, FDA generally accepts up to 3 years shelf life when you have
1) data for functional shelf life using an accelerated aging approach as described in ASTM-F1980
2) a protocol for the real time testing, which you'd be expected to submit when results are available.

You'll need to understand the issue that your reviewer has with the submission. This may be anything from missing data (which you may have submitted, but which never reached him, because it was sent to another reviewer) over a simple misunderstanding to a real issue she/he has regarding safety and/or effectiveness.
If it is really about the validation of the aging protocol, you could offer to send interim reports on the real time aging tests and use the 6m and 1y data to validate the aging protocol, so you'd not have to wait for 3 years real time data to validate your approach.
 
N

NicoleinFlorida

Re: Question about Accelerated Aging

Hello TWA,

Thank you for the response. During the submission, we provide additional testing information to FDA. But, I think you are right, it seems like the reviewer who sent the comments to use did not see those additional information.

Based on your comments, we can submit a 3-years shelf-life with accelerated aging, and a 1-year shelf-life with real time aging to valid the accelerated aging. Is that correct?

Recently, we just reached 1-year real time aging.

Thank you again.

Nicole
 

TWA - not the airline

Trusted Information Resource
Re: Question about Accelerated Aging

Hello TWA,

Thank you for the response. During the submission, we provide additional testing information to FDA. But, I think you are right, it seems like the reviewer who sent the comments to use did not see those additional information.

If the additional information in any way addresses the questions you got back, I'd re-submit this and try to get a clarification on what is considered missing. Maybe you are lucky and they do not ask for more...

Based on your comments, we can submit a 3-years shelf-life with accelerated aging, and a 1-year shelf-life with real time aging to valid the accelerated aging. Is that correct?

Recently, we just reached 1-year real time aging.

This may be something you could try to offer when this problem persists. Depending on what the reviewer thinks is the issue it may not be enough...
Of course, having passed the 1y real time data just proves a shelf life of 1 year (which may in the worst case be something to start with rather than wait 2 more years before marketing the device) but does not validate your aging protocol. However having interim data should also help your cause.
But you can beef up this line of argument if your protocol allows you to statistically compare variable performance data rather than just PASS/FAIL between the 1y real time and the 1y accelerated samples. Best would be if you had something to address every failure mode of the device that you considered in the risk analysis. This should be an acceptable validation approach. But I understand things are already well underway and probably cannot be changed.

Hope this helps.

Best,

TWA
 
N

NicoleinFlorida

Re: Question about Accelerated Aging

Thank you again.

Our protocol include all tests conducted with non-aged products, performance, functionality, and package integrity. And some of the testing results are quantitative, so we can perform the statistical analysis to have a better argument.

If we provide 1y real time and 1y accelerated testing, we can only claim 1-year shelf-life. Besides that, what if we could also provide 3-year accelerated testing, could we claim 3-year shelf-life in the application?

I really appreciate your response. It is very helpful.

Nicole
 

TWA - not the airline

Trusted Information Resource
Re: Question about Accelerated Aging

Nicole,

if you validate the aging protocol with the comparison of 1y real time vs. 1y accelerated aging, than you can use the 3y accelerated aging data to claim 3 years shelf life. Based on your first post I would imagine that this is probably what FDA is looking for. You'll also need to provide the protocol of the real time testing and submit any interim data you have, but this is the usual approach which is generally accepted. You can verify the validation you did with the 1y data once the 2y real time data becomes available and also submit this interim...

Best,

TWA
 
G

gholland

Sounds like the reviewer is not familiar with the materials you're using and wants to understand if the material that has seen accelerated aging has the same properties as the real time aged material. It doesn't sound like they're after functional testing from your question, it sounded like they are wanting proof that your accelerated aging doesn't change the materials you are using in such a way that they would have different material properties than materials that have not seen elevated temperatures. If they are different then you can't use accelerated aging to substantiate shelf life and would have to find another way to age the product, likely at lower temps for a longer time.

That's how I read the question.

:2cents:
 
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