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Unpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?

Health Law Advisor

SEPTEMBER 5, 2023

It’s common for a client to show up at my door and explain that they have performance data on a medical device they have been testing, and for the client to ask me if the performance they found is adequate to obtain FDA clearance through the 510(k) process. But recently I wondered, what do the data say regarding cleared medical devices?

FDA

FDA Unlocks the Key to Innovation in Interoperable Medical Devices

Exeed Regulatory Compliance

FEBRUARY 25, 2020

Interoperability holds the key to interconnected medical devices. At home, at work, and in public places, we are using devices and systems that are connected to the internet and to each other. Nearly every aspect of our lives is now dependent on these smart devices. We live in an interconnected world.

FDA

Unpacking Averages: How Accurate Do Class II Medical Devices Need to Be to Obtain 510(k) Clearance?

FDA Unlocks the Key to Innovation in Interoperable Medical Devices

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