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ANT For Medical Devices - FDA, 510(k), other regulatory hurdles

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Total Posts: 523

Joined 2012-11-15

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What predicate devices currently use ANT?

We're investigating the possibility of including ANT in our medical device, but I want to make sure it will make it though the pre-market notification process with the FDA.

Does any documentation exist to help medical device manufacturers with this process?      
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Total Posts: 662

Joined 2012-10-09

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Please contact us directly with more details about the type of the device you are looking into, to see how we could help with the process.