U.S. Food and Drug Administration (FDA): FDA Breakthrough Device Designation

The FDA Breakthrough Device Designation is recognition by the US FDA that a device in development should be prioritized for patient access as it has a good chance of providing better treatment than the current standard of care for life-threatening or debilitating diseases or conditions. To be eligible for breakthrough status, the device must meet at least one of the following four criteria: it is a breakthrough technology, there are no existing alternatives, it offers significant advantages over existing alternatives, or its availability is in the best interest of patients. Once a device has been designated as a breakthrough device by the FDA, it will be assigned a Q-sub reference number for all future communications with the FDA.

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