Labeling Requirements for Free Samples supporting Clinical Evaluation

Z

zolakeene

#1
HI Guys

I have a query?
I have been giving away free samples for clinical evaluation, my query is this acceptable and do I need to identify them in a particular way?
 
Elsmar Forum Sponsor

v9991

Trusted Information Resource
#2

Ronen E

Problem Solver
Staff member
Moderator
#3
HI Guys

I have a query?
I have been giving away free samples for clinical evaluation, my query is this acceptable and do I need to identify them in a particular way?
Clarifications required...

What is the regulatory status of the devices?
Where are they being "evaluated"?
What is the nature of what you refer to as "clinical evaluation"? Are you gathering opinions from clinical practitioners / institutions, or are they actually being put to use on humans?
What is the purpose of the evaluation? Are you trying to build a case for you Technical File clinical evaluation?
Etc.

Whether or not you're being paid for those devices is most likely irrelevant from the regulatory perspective.
 
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