Bench Testing

A

aravindh

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#1
#1
Hi all

This is a scenario based question. I am intending to bring my device into the US market via 510(k) application.

I am planning conduct bench testing for my medical device. To conduct that testing I need other (compatible) medical devices. I have selected the compatible medical devices based on worst case scenarios. But the compatible medical is not legally marketed in the United states. Can I use these medical devices to perform the bench testing?
 
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chris1price

chris1price

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#2
#2
Probably not, the point of a 510(k) is to show equivalence to a device already approved on the US market. If the comparative device is not approved, then FDA can't approve yours.
 
A

aravindh

Starting to get Involved
#3
#3
chris1price said:
Probably not, the point of a 510(k) is to show equivalence to a device already approved on the US market. If the comparative device is not approved, then FDA can't approve yours.
Click to expand...
Hi Chris,

Thanks for the response. I understand that, the medical device used for proving substantial equivalence for the newly marketed device should be a legally marketed device in U.S market.
The scenario is like, the new device is tested with a worst case device (which is compatible) to prove the performance of the new device using bench test. If the medical device, which is used along with the new device only for the worst case testing but it not will be marketed along with the new device
 
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