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510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review

This draft guidance outlines FDA’s current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by describing FDA’s expectations for the reviews of 510(k) submissions and EUA requests by third party review organizations. This draft guidance provides updated recommendations on the 510(k) Third […]

Mittal Consulting New Hires 2024

We are ecstatic to welcome our newest team members in the new year 2024! With valuable expertise and unparalleled ambition, our new hires are ready to expand Mittal Consulting services globally! Welcome Shu Xiang, Elle Winn, Shambhavi Sharma!

What is Ethylene Oxide (EtO) sterilization? Benefits, Cancer Risk and Regulatory perspectives

Elle Winn What is EtO Sterilization? Ethylene Oxide (EtO) gas sterilization is one of the most common sterilization methods used for medical devices. The practice is critical to sterilizing temperature- or moisture-sensitive devices1 and is very efficient for sterilizing devices with complex geometries with limited access2. For some devices, EtO gas sterilization is the only […]