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What is Breakthrough Device Designation?

The FDA Breakthrough Device Designation is a formal identification by the US FDA that a device in development should be expedited for patient access because it has a reasonable chance of providing more effective treatment than the standard of care for the treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. To be granted breakthrough status, your device must also meet at least one of the following four secondary criteria: 1. Represents Breakthrough Technology 2. No Approved or Cleared Alternatives Exist 3. Offers Significant Advantages over Existing Approved or Cleared Alternatives 4. Device Availability is in the Best Interest of Patients Once the FDA has designated your device as a breakthrough device, all future communications with the FDA related to that device should be identified with the Q-sub reference number assigned to your breakthrough request. The FDA Breakthrough Device Designation was created in 2015 to expedite device access for life-threatening and debilitating diseases. If you would like to learn more about this program or you need help preparing a request for designation, please visit Medical Device Academy's Blog on this topic: ➤ https://medicaldeviceacademy.com/brea... If you want more information, please schedule a call with us: ➤ https://medicaldeviceacademy.com/cont...