Medical Device Aging & Safety Questions by FDA

Szaki87

Registered
Hi All!
We are trying to register our medical device class IIa to the U.S. Market.
There is a muscle stimulator which has accessories: pads and clothing and wires which provides the connection between the device and the pads/clothing.

Is there any ISO standard which is in correlation with any FDA guidance which is in relation the below mentioned FDA request?

The FDA has asked that we have to provide the following:

Summary of the methods used to establish that the device and its components are not adversely affected by aging.
Rationale why storage conditions are not expected to affect device safety and effectiveness.
Please provide this information at your earliest convenience and let us know if you have any questions.

"You don't have to write a technical document. You can just summarize the standards that were used to conduct the aging testing. If the standards are not recognized by FDA or if you didn't test according to a consensus standard, you will likely need to provide the test report (protocol, results, and conclusion), as well."

Well we have determined 800 working hours/5 years for the clothes and pads.
We have determined 5 year expected lifetime for the medical device /or 1000 working hours maintenance period.

Could help me someone? Sorry for my english.
Thank you,
Attila
 

Szaki87

Registered
Hi Sreenu,

I has known this page but my problem is that I didn't find any ISO standard or method which is related to the medical device aging testing. Only we can ask our suppliers about the components of the device to give any results of the material testing, etc.
The Medical Device Directive (Council Directive 93/42/EEC) allows to determine the expected lifetime by the manufacturer if well know.
Is there any method or standard for aging test of medical device?
I have read about shelf life of medical device accessories (which are sterilized) but this device accessories are only disinfected, not sterilized. Or can I use the shelf life for disinfected parts/accessories of medical device?

Thank you,
Attila
 

sagai

Quite Involved in Discussions
Hello there! (nicsak egy m?sik magyar sr?c is van itt :) )
Some clarification first.
For US, there is no such classification like Class IIa I do not know if you referred to US with this numbering, this kind of classification is for EU. Classification is determined by the corresponding CFR of the particular device, so you need to double check it if it would be the case.

Yesss, there are some recognised standards for US, however it works slightly differently than in the EU. For EN versions the vast majority of the standards are explicitly defines that in what extent the particular standard provides presumption of conformity to the corresponding MDD. There is no such explicit statements for US legislation.

I do not know any specific standard for thes aging testing to be honest and I have never come across with any. Hopefully other fellow covers may had.

The other thing is that as per the sentence you have provided it is pretty much up to you if you may consider your own way as a golden one, only the extent of the documentation to be submitted to FDA would be a wee more detailed.

Cheers! (Haliho :) )
 

Szaki87

Registered
Thx sagai the reply! (igen, sok inform?ci?t szerztem m?r erről a f?rumr?l, v?gre elhat?roztam, hogy regisztr?lok is :))
We hadn't answer still to FDA in relation this issue. I think they have a document with many checkpoins and these questions are one of them :)
My problem is how to "clever" answer for FDA to get few problem from this issue/question.
If anyone had ever such issue with FDA please be so kind give me feedback.

Thx again,
Attila
 
M

MIREGMGR

The issue is functional stability.

Over time, what deteriorative or wear mechanisms may affect that functional stability? You should be able to determine that by a combination of engineering analysis and experience/observation of similar devices, or dissimilar devices that utilize some of the same materials or technology, already on the market.

Once you've identified those mechanisms, you proceed to force its effect under test. If it's number of cycles of operation, you set up a test rig to accumulate the target number of cycles, or operate it until it breaks or otherwise is degraded. If it's a material change over time, you determine if its effect can be temperature accelerated, and if so you use well-known accelerated aging approaches.

Document what you've done. If you have no gaps, FDA may be satisfied.
 
M

mr.mike

Hi Attila,
I agree with MIREGMGR. As far as I know there is no general "aging testing" standard, so you pretty much have to make your own.

Well we have determined 800 working hours/5 years for the clothes and pads.
We have determined 5 year expected lifetime for the medical device /or 1000 working hours maintenance period.

How did you arrive at these figures? If you have some justification for this, for example:
- by examining other devices using the same materials, or
- by conducting your own material durability tests and/or cycle testing,
this likely would be sufficient...

MM
 
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