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• Breakthrough Devices Program - Presentation

On January 17, 2019, the FDA will host a webinar to help clarify the Breakthrough Devices Program final guidance for manufacturers.

On December 18, 2018 the FDA issued the final guidance document that outlines program policies, features and the process for manufacturers when pursuing the breakthrough designation.

The Breakthrough Devices Program is one of the FDA’s initiatives that promote patient access to innovative and potentially safer new therapies and diagnostics. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to devices that treat or diagnose a life-threatening or irreversibly debilitating condition. These devices offer new ways to treat or diagnose a disease, have significant advantages over existing treatment alternatives, or provide another public health benefit.

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

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