What You Need to Know About FDA Breakthrough Devices
Update: 2025-06-16
Description
The FDA Breakthrough Device Program offers a expedited path to market for medical devices that offer more effective treatment or diagnosis for life-threatening or irreversibly debilitating conditions. It allows for prioritized review and enhanced communication with the FDA to help bring innovative devices to market more quickly, but it's not for everyone.
In this podcast, Michelle reviews the specifics of the program - the benefits, the requirements, the challenges - and talks about how you can decide if the program is right for you and your device.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa
In this podcast, Michelle reviews the specifics of the program - the benefits, the requirements, the challenges - and talks about how you can decide if the program is right for you and your device.
LinkedIn: https://www.linkedin.com/in/michellelottraqa
Website: https://leanraqa.com/
YouTube: https://www.youtube.com/@leanRAQA
Instagram: https://www.instagram.com/leanraqa
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