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How to interpret the definition of clinical and preclinical trials?

N

normhowe

#1
Hello,

We are trying to define the differences between pre-clinical and clinical research. We have a simple class 2 device. Let's just say for the purpose of discussion that it is worn on the wrist. If, during the design of a modification of the device, we were to try the device on our own wrist, just to see if it fits. Would that be considered a clinical trial? thus requiring an IDE and approval from an IRB?
 
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Stijloor

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#2
Re: How to interprete definition of clinical and preclinical trials?

A Quick Bump!

Can someone help with this question? Thank you very much!
 
#3
Re: How to interprete definition of clinical and preclinical trials?

Exempt Studies
In accordance with 21 CFR 812.2(b), sponsors and investigators of certain studies are exempt from the requirements of 21 CFR Part 812, with the exception of §812.119 (disqualification of a clinical investigator). Examples of exempt studies are consumer preference testing, testing of a device modification, or testing of two or more devices in commercial distribution if the testing does not collect safety or effectiveness data, or put subjects at risk
From here:
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM127067.pdf
 

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