Breakthrough Device Designation Timeline Explained

Considering the FDA's Breakthrough Device Designation (BDD) program for your innovative medical device? Proxima's Director of Regulatory Affairs and Quality Assurance, Ellie Reynolds, walks through the complete BDD submission timeline, from initial application to FDA decision, so you know exactly what to expect during this expedited approval process.

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Timeline Breakdown:

📅 Day 0: FDA receives your completed designation request

📅 Day 30: FDA requests additional information (if needed)

📅 Day 15 (after request): Your deadline to provide requested information

📅 Day 60: FDA decision letter (granted or denied)

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What Is Breakthrough Device Designation (BDD)?

The Breakthrough Device Designation program accelerates access to devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Want to learn more? See if your device qualifies for BDD with this quick 2-minute quiz!

Successfully getting your device approved and into the hands of end-users while maintaining regulatory compliance across global markets is a challenging process. Proxima's team of regulatory experts can guide your medical device through the Breakthrough Device Designation process.

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