Medical device license (Class III device) applications required to provide the following informations:

"A summary of all preclinical physical testing, such as stress, fatigue, wear and shelf life, all biocompatibility testing and the results of all animal and previous clinical investigations."

1) What does "preclinical physical testing" really mean?
2) How to provide animal and previous clinical investigations? Does that mean we need to do the clinical study?

Thanks

Can anyone help with this one?

Medical device license (Class III device) applications required to provide the following informations:

"A summary of all preclinical physical testing, such as stress, fatigue, wear and shelf life, all biocompatibility testing and the results of all animal and previous clinical investigations."

1) What does "preclinical physical testing" really mean?
2) How to provide animal and previous clinical investigations? Does that mean we need to do the clinical study?

Thanks



0 - clinical investigation = human clinical trial

1A. Preclinical - tests/research (etc) that take place before testing on human subjects
1B - physical testing - this is typically proving that the "engineering design" is adequate, by labwork.

2 - the requirement is to provide adequate evidence that your design is safe AND clinically effective. There are multiple ways to achieve that, including performing your own animal trials and then human trials. However the sentence includes "previous". Thus it is possible that if there is existing data (from published scientific papers for example) that you won't need to do a clinical trial at all.


This is a huge and complicated subject, and to be honest if you are asking basic questions like this - for a highest-risk device - my best advice is to get specialist help.

Another very good explanation about the preclinical testing can be found at
the attached document

BUT what's the difference between Preclinical physical testing and Preclinical animal testing?

You are probably over-thinking this.

Preclinical testing means everything you need to do before the prototype is used on a human being. That can be a combination of (for example:

life-science laboratory testing (biocompatibility),

engineering laboratory testing (is the device robust enough to work not just once, but the 10,000 times it will be used in its intended lifetime),

animal testing (i.e. we won't implant the device in a human trial just yet, let's see if it works in an appropriately similar animal first)



There are likely many other things that would fall under the banner of preclinical testing.

What I would say though is that animal testing is the penultimate thing you do (i.e. human trials are the last thing). The other in-vitro tests you perform can be done in any sensible order.