Vivos Inc (RDGL): The guidelines mention nothing of certif...

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Re: CatfishHunter post# 171252

Wednesday, 02/28/2024 3:51:30 PM

Wednesday, February 28, 2024 3:51:30 PM

The guidelines mention nothing of certification

812.43 Selecting investigators and monitors.

(a) Selecting investigators. A sponsor shall select investigators qualified by training and experience to investigate the device.

Why would companies offer certification to a product that might not make it to market.

There are plenty of examples out there showing clinical trials started without any form of certification.

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