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DRV8428: Adoption for medical equipment

Part Number: DRV8428

Dear Teams,

I would like to use this product for an FDA Class II medical equipment. It is not a life-critical medical equipment.
Do I need a special permit to use the parts?

Please let me know if there are any restrictions such as the need for an additional contract.


Also, please let me know if there are any precautions when using it for medical devices.

thanks!