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
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