Do models created with NVIDIA Clara require FDA approval for clinical use?

Hey all, I’m diving into the regulatory principles around applying AI in a medical workflow. I was wondering if FDA approval is required prior to deploying a -let’s say brain tumour segmentation- model created with NVIDIA Clara for clinical use? If not, do you have any idea why? Your input is much appreciated!


Thank you for your interest in the Clara Train brain tumor segmentation pre-trained model. Those models are intended to accelerate research work and will require additional scrutiny before use in a clinical setting. The terms of use are further explained in the Grants section of the Clara Train EULA (End User License Agreement) here: NVIDIA Clara SDK License_13_Mar_2020.pdf

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