Breakthrough Device designation
What is the Breakthrough Device designation?
The Breakthrough Device designation is given by the Federal Food and Drug Administration (FDA) to certain medical devices and device-led combination products.
Devices that are eligible for Breakthrough Device designation include those that provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating diseases or conditions and meet at least one of the following criteria:
- Represents breakthrough technology
- Offers significant advantages over existing cleared or approved alternatives
- Has no approved or cleared alternatives
- The device’s availability is in the patient’s best interest
A Breakthrough Device designation request can be sent any time before sending a market submission, whether the submission applicable for the device is a pre-market notification (510(k), pre-market approval (PMA), or De Novo classification request. Information to include in the request is a description of the device, regulatory history, the proposed indication for use, how the device meets the criteria for a Breakthrough Device, and the type of marketing submissions that will be submitted to the FDA for the device.
What is the benefit of a Breakthrough Device designation?
The Breakthrough Devices designation allows manufacturers to interact with FDA experts throughout the pre-market review phase, helping to address topics as they arise and respond in a timely manner. A Breakthrough Device designation also allows for a prioritized review of the device’s submission.