Скачать или смотреть Premarket Approval Application and Humanitarian Device Exemption Modular Review​

The FDA’s Modular Review pathway for Premarket Approval Applications (PMA) and Humanitarian Device Exemptions (HDE) helps sponsors streamline submissions and reduce delays.​

🔑 5 Key Takeaways from the Guidance:​

✅ Submit applications in stages for efficiency​

✅ Use a “shell” to define module structure and timelines​

✅ Each module reviewed in ~90 days with feedback​

✅ Early issue resolution reduces risk at final submission​

✅ Final module completes the package for FDA decision​

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🎥 Watch our short video to understand how modular review supports efficiency, predictability, and earlier FDA feedback in device development.​
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📄 Full guidance here:​

https://www.fda.gov/regulatory-information...

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