Buying a competitors product for SE testing


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Following on from a thread on Linkedin which I thought was interesting I thought I would pose the question here to see if anyone had any different thoughts...

It seems as if some people think that comparative testing is not required to demonstrate substantial equivalence.

For the flowchart in the FDA's guidance document, decision 4 states:

"do the different technological characteristics of the devices raise different questions of safety and effectiveness?"

To answer this question we always performed comparative testing and then used the t-test or anova to show that the results obtained for that test are substantially equivalent.

Therefore, we have always had to resort to buying competitor products from ebay in order to do comparative testing between them.

I cannot understand how we would be able to prove substantial equivalence without performing comparative testing?

Does anybody have any thoughts on this?



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I personally can't help, but here is a quick "Bump" - My Thanks in advance to anyone who can help with this one.


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In my opinion and experience, you do not have to submit comparative or side-by-side testing. It's great if you can, but that only works if you have access to the predicate and your device is nearly identical to the predicate. Many times that is not an option, nor a requirement.

To compare you device to a predicate, select characteristics, features, and parameters. Some can be compared without testing by qualitative means, for example, intended use, indications, target population, anatomical site, etc.
For quantitative characteristics you can use guidance documents, standards or accepted industry specifications (biocompatibility, electrical/mechanical safety), or frequently the competitor will post specs that have specific values or parameters. Once you have those, you can test your device to show that it meets these specs.


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Some device specific FDA guidances require performance testing, but many do not.
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