Medical device

FDA's Breakthrough Devices Program Update October 2023

FDA Finalizes the Breakthrough Devices Program Guidance

October 9, 2023
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policy update

Overview of FDA's Breakthrough Devices Program Final Guidance

In a rapidly evolving landscape of medical technology, the FDA is committed to harnessing innovation to enhance public health. The Breakthrough Devices Program, initiated in 2015, has seen remarkable growth, granting Breakthrough Device designation to 831 devices and authorizing 77 with this designation as of June 30, 2023. This voluntary program aims to expedite the development and approval of medical devices designed to treat life-threatening or debilitating diseases.
A key milestone is the release of an updated final guidance for the Breakthrough Devices Program, emphasizing health equity. The FDA recognizes the need to ensure timely access to high-quality medical devices, especially those addressing health disparities. This guidance clarifies how the program can apply to devices that promote health equity and addresses the interpretation of "more effective" in device assessment. It also highlights the importance of improved accessibility and transparency in device authorization.
Moreover, the Breakthrough Devices Program is further supported by Regulatory Science Tools (RSTs) and the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot. RSTs offer valuable tools for device development, while TAP aims to streamline the medical device development process through proactive engagement with stakeholders.
To learn more about these developments, the FDA will host a webinar on November 14, 2023, providing insights into the updated final guidance and the future of the Breakthrough Devices Program. This commitment to innovation and health equity underscores the FDA's dedication to advancing patient care and public health. Checkout the link to the webinar below.

Link to webinar