CytoSorbents Corporation (CTSO)

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This page tells you everything you need to know about the Breakthrough Devices Program

https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program


What is the Breakthrough Devices Program?

The Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency's mission to protect and promote public health.

The Breakthrough Devices Program replaces the Expedited Access Pathway and Priority Review for medical devices. The FDA considers devices granted designation under the Expedited Access Pathway to be part of the Breakthrough Devices Program.

What are the benefits of the Breakthrough Devices Program?

The Breakthrough Devices Program offers manufacturers an opportunity to interact with the FDA's experts through several different program options to efficiently address topics as they arise during the premarket review phase, which can help manufacturers receive feedback from the FDA and identify areas of agreement in a timely way. Manufacturers can also expect prioritized review of their submission. Learn more about the Breakthrough Devices Program principles and features in Sections II and IV of the Breakthrough Devices Program final guidance.

What a sponsor can expect from FDA if Breakthrough Designation is Granted

If your device is granted the Breakthrough Device Designation, you can choose to interact with the FDA to obtain feedback on your device development through a variety of options including sprint discussions, request for discussion on a data development plan, and request for clinical protocol agreement. Learn more about these options in Section IV of the Breakthrough Devices Program guidance.

You will also receive prioritized review on future regulatory submissions, including Q-Submissions, Investigational Device Exemption (IDE) applications, and marketing submissions.