What Constitutes "Manufacturers Claims" about a product?

S

s.parakos

#1
All medical devices need a Clinical Evaluation Report to help substantiate the manufacturers claims.

My question is, what constitutes the manufacturers claims, and what can be put in the basket of marketing hype?

In product literature, a product can be described as "convenient", "simple" or "easy to use". Are these terms part of the manufacturers claims that have to be substantiated and if so how would one go about providing the evidence required?

thanks
Simon
 
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yodon

Staff member
Super Moderator
#2
From my experience (with the US FDA), anything documented is a potential claim. Certainly many regulatory actions have been taken based on "marketing hype."

Again coming from a US FDA perspective, the validation process has to confirm the device meets user needs and intended use. If it is marketed as 'convenient' then there probably should be some evidence that your end users generally agree that it's convenient to use. For such subjective aspects, I have seen feedback from focus groups (intended users getting to operate the device) used.

I expect most inspectors, though, would not focus too much on such 'fluffy' statements and focus more on safety and efficacy.
 
S

sshankle

#3
I agree that the "fluffy" stuff is low risk from a compliance perspective, and you better have yourself covered regarding anything quantatative. But, I listed a few qualitative phrases below to watch-out for, to get you mind working. Also, industry presentations can be monitored for "claims", such as at a physician conference.

Some potential "Claims" to watch-out for:
"No Failures"
"Better than ..."
"Stonger than Ever"
"More Accurate than ..."
"New and Improved"
Anything safety or effectiveness related that is unsubstantiated (or not part of clearance)

Hope that helps. Good luck.

Scott
 

Marcelo

Inactive Registered Visitor
#4
From my experience (with the US FDA), anything documented is a potential claim
Very well, but i would include everything implicit (not necessarily documented) as a claim as well. This is in line with the usability of the device, let´s say that the manufacturer has an advertising / manual that can lead the user to use error because of some implicit action / definition.

This takes things to the next level, meaning, everything could be a claim, but i think it´s really this way anyway.
 
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