FDA Breakthrough

The purpose of this program is to accelerate the availability of devices that may address important health challenges.

This program is further depicted on the following link.

This interesting program consists of two main stages. In the first stage, the company must submit a designation request to apply for entry into the program via the Q-Submission process. This request can be sent at any time before a marketing submission (PMA or 510(k) or De Novo classification request)

The application must describe the device, its proposed indications for use, how it would benefit the target patient population, its regulatory history, and the type of marketing submission to be submitted to the FDA. Sponsors also must identify how the proposed device meets the Breakthrough Device acceptance criteria. The FDA intends to respond to designation requests within 30 days, generally requesting additional information the Agency deems necessary before making a decision about the device’s inclusion in the program. The FDA aims to reach a decision to grant or deny the request for designation within 60 calendar days of receiving the application.

Inclusion in the FDA Breakthrough Device program is dependent on two criteria. First the device must provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. Second, the device must meet any one of the following: the device represents breakthrough technology; no approved or cleared alternatives exist; the device offers significant advantages over existing approved or cleared alternatives; or, device availability is in the best interest of patients.

Medidee supports the evaluation for your device of the feasibility of such an approach and the preparation of the submission documentation.