purpleandpenguins

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purpleandpenguins101 karma

Hi Doctors,

I'm a Michigan Engineering student and I'm currently taking a class on Global Quality Systems and Regulatory Innovation (BIOMEDE 599).

I saw that you received emergency clearance from the FDA to implant both Kaiba and Garrett. How will the FDA and related regulatory bodies affect the way this process is used in the future? Have you run into any interesting regulatory roadblocks while developing this?

Go Blue!

purpleandpenguins14 karma

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