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CalAttorney2
CalAttorney2, Attorney
Category: Business Law
Satisfied Customers: 10238
Experience:  I am a businesses law attorney, with experience advising and representing owners and investors.
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I have a medical device (a muscle stimulator) that I will be

Customer Question

I have a medical device (a muscle stimulator) that I will be demoing at a trade show where the general public will be in attendance. It is not yet FDA approved but people may want to test it. Can I have them sign a waiver relieving me of any responsibility
in case of injury or should I simply have no one test it. Since I am at a trade show, I would like consumer feedback but I don't want to be subject to any silly lawsuits.
Submitted: 1 year ago.
Category: Business Law
Expert:  CalAttorney2 replied 1 year ago.

Dear Customer, allowing people to "test" a non-approved medical device (at a trade show, or anywhere else outside of an FDA approved study), is a sure way to find yourself as a defendant in a very real (and non-silly) law suit. I wouldn't recommend this course of action, if you need feedback regarding the efficacy of your device as a medical treatment, you need to set up a medically appropriate test with controls and get information that way - having people try it out at trade centers is not how this is done.

Customer: replied 1 year ago.
No I am not doing it as a means of testing my product. That is already ongoing. I am simply demoing it at a trade show as a way of building awareness of what it can do. However for the casual person who walks up and wants to try it, can they sign a waiver relieving me of any responsibility or should I say "no, you can't try it because it is not yet FDA approved".
Expert:  CalAttorney2 replied 1 year ago.

Dear Customer,

You are selling your device as a "medical device" (I assume this is similar to a "TENS Unit"), if you compared it to a medication, it may make it easier - if a person were to approach you and ask to test a pill to see if it worked, you would not give it to them to "try it out"

If this was a non-medical device - you were selling a massage chair, or something of that nature, not requiring FDA approval or falling under those regulations, then you could have someone try it without any concerns, but that does not appear to be the case with your device (which is awaiting FDA approval, I assume for the treatment of diagnosed injury(ies) and/or illness(es) which would likely require a physician's diagnosis as well as a prescription for the device (none of which would happen with a bystander at your trade show).

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