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Please see answers to several questions asked during the webinar below!
The requirements and approach for this type of device will depend on a number of factors such as, the residual risks for the device, the expected clinical benefits, whether standards or common specifications exist for the device, and more.
Without knowing the specific device, it would be difficult to define a specific approach, but in general, if the device provides clinical benefits, clinical evidence will be required. If no clinical evidence currently exists on the device or equivalent devices and the clinical benefits cannot be justified or substantiated by testing or adherence to a standard/common specification, manufacturers will need obtain clinical evidence for their device either through clinical studies or through other data such as surveys or focus groups.
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