Product Performance Claims

#1
was told by auditor that our device "performance claims had yet established for the function of cavity cleanness claimed in intended use"
reading through the guidance, it still seems fairly vague to me as to what is performance claim "Behavior of a medical device or response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s)."

is it the statistical efficacy of its intended use?
 
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yodon

Staff member
Super Moderator
#2
What are your performance claims? How do your specifications elaborate those? What clinical data do you have to support your claims?
 
#4
We don't technically have performance claim. Just intended use, hence the "performance claims had yet established"
Is performance claim a requirement? and how does it differ from the intended use?
 

yodon

Staff member
Super Moderator
#5
Unless you're exempt from design controls, a typical hierarchical structure comprises the set of user needs and intended use which are then translated into system / functional requirements. The user needs and intended uses are validated and the system / functional requirements are verified. Without knowing more about your product or your development process, it's difficult to address the question. At some point, your product has to do something and they may be suggesting you don't have sufficient objective evidence to support that.

If your regulatory route is a 510(k) then you should be able to look at your predicate device to see what (performance) testing was done.
 
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