A Brief Overview Of The Breakthrough Device Designation Program

Advancements in healthcare technology are progressing at an extraordinary pace. Innovations aimed at improving patient care, facilitating diagnostics, and enhancing prognoses are emerging almost daily. With these rapid developments, regulatory bodies face challenges in keeping up. To address this, the Food and Drug Administration (FDA) launched the Breakthrough Device Designation (BDD) Program in 2018. Here’s an overview of the program and its role in advancing medical devices.

In the United States, the FDA is responsible for ensuring the safety, quality, and effectiveness of a broad range of medical products, including devices. The FDA aims to accelerate the time it takes for more effective or affordable innovations to reach the market without compromising safety. The BDD Program was established to expedite access to groundbreaking devices.

Initially, the program replaced the Expedited Access Pathway (EAP) and Priority Review Process for medical devices. Devices previously granted designation under the EAP are now part of the Breakthrough Devices Program. Since its inception, over 728 Breakthrough Device designations have been granted, including those initially designated under the EAP.

How does this voluntary program function? Once a device is designated as a breakthrough device, the FDA works to expedite its development, assessment, and review. Although the process is accelerated, the device must still meet the regulatory standards for premarket approval, 510(k) clearance, or De Novo marketing authorization. The program covers both medical devices and combination products.

To qualify for the designation, a device must meet specific criteria. First, it must demonstrate that it can more effectively diagnose or treat life-threatening or irreversibly debilitating diseases or conditions. Additionally, it must meet one of the following: it offers a significant improvement over existing alternatives, it is in the best interest of patients, it provides substantial advantages over existing approved or cleared alternatives, or device availability is in patients’ best interests.

Companies, manufacturers, or sponsors can request a designation by submitting a Breakthrough Device Q-Submission. Occasionally, the FDA may invite innovative devices that meet these criteria to apply. The FDA provides guidance documents outlining how to navigate the process. For expert assistance, firms may consider engaging neurological device consultants specializing in obtaining Breakthrough Device Designation.

For further details on the Breakthrough Device Designation Program, please visit the FDA’s website.