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The U.S. Food and Drug Administration (FDA) is announcing a public webinar: Breakthrough Devices Program Updated Final Guidance. The purpose of this public webinar is to discuss the updates made to the final guidance, share how the program can help advance health equity, and answer questions about the guidance.
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Webinar Date: Tuesday, November 14, 2023, from 1-2 p.m. ET
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Location: Virtual - Click on Webinar Details below for the webinar link.
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Registration: Not required.
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. The program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization.
Questions?
If you have questions about this public webinar contact the Division of Industry and Consumer Education.
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