Hello Anon,
This can be a tricky situation and would probably need to know more about what is the device, circumstances it is being used in publicly, how it is being used, and what affect or results are being provided to the patient. Certainly any non-cleared or non-approved medical device used with, on, in, or by a patient needs to have a proper clinical trial in place, protocol, case report forms, and importantly informed consent. There are some "loose" guidelines or industry advice provided by US FDA on showing non-cleared/non-approved devices at trade shows or conferences.
If the device is going to be used with a patient, think about ways the device can be "deactivated" or does not provide any results or fully do the action intended. If the intent is to get users feedback on the device, such as a prototype, there can be ways to stay out of regulatory harm by making the device non-functional or not providing any results to the patient. Then the person can turn it on, look at the interface, manipulate, and try it out. Of course, this is highly dependent on the device and what it does. The device should be clearly labeled as "Not for Human Use" so if being used with a patient - there are three basic options: 1) non-functional for seeing only 2) investigational device labeled properly or 3) cleared/approved. You can not have someone sign a document getting out of things legally or from a regulatory standpoint, so really it is a challenging situation being proposed; use caution with this approach.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Principal Strategy Consultant
NAMSA
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Original Message:
Sent: 17-Apr-2024 05:05
From: Anonymous Member
Subject: Legal and Regulatory Considerations for Pre-Market Device Demonstrations Involving Patients
This message was posted by a user wishing to remain anonymous
Hello everyone,
I am seeking guidance on conducting pre-market investors demonstration roadshow using a Class II medical device, where the patient actively operates the device. This is analogous to our future product to be submitted for FDA clearance.
What are the critical legal and regulatory factors we need to consider before having a patient participate in such a public demonstration? For instance, is a consent agreement and insurance coverage sufficient to mitigate legal risks, such as potential adverse events during the demonstration?
Moreover, could you advise on any specific clauses that should be included in the consent contract to protect all parties involved? Are there particular implications we should be aware of from a regulatory standpoint, such as those from the FDA, that could affect us due to conducting such a demonstration?
I appreciate any insights or references to similar cases and the best practices to follow.
Thank you in advance for your assistance.