What are the regulatory requirements for the intended purpose statement and why are companies struggling with compliance?

It’s really easy to go a little off the rails. I could say my intended purpose is I’m going to measure this enzyme because it is an indicator of inflammation. That sounds all well and good, and then all of a sudden you start to publish information and you start to advertise in cardiology journals and you start to put some things out there. Now all of a sudden your intended purpose has gone from: I’m measuring this enzyme to I’m going to predict whether you’re going to have a heart attack in the next five years. And the data and everything you need around that changes when you change that intended purpose.

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