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.


We are passionate about your success. Tell us more about your regulatory and quality needs so we can help.

Book a Consultation

GLOBAL BOTTOM CTA INSTRUCTIONS:

To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!