EPAT General Discussion, page-944

I was a holder of RAP from Aug 15 to Aug 17. The differences I see in the testing/results of EPT are
- as a Class 1 product the testing requirements are less stringent and the review by FDA of submissions is much shorter. FDA may however require testing to be done in US, irrespective of any testing done elsewhere to date
- EPT has peer reviewed results published in a highly respected international journal
- EPT has done further more widespread testing (also peer reviewed) using the commercial version of the app which was refined from feedback in using the app in ‘the workplace’.
- the current ‘gold standard’ (i.e the Abbey pain scale) is a very clear benchmark, and the app has been proven to be at least equal to it in two peer reviewed studies.

In my opinion, it’s as close to being thoroughly proven as one could expect at this stage. The testimonials from the aged care facility in the Barossa were very convincing for me, as it demonstrated it’s value at the point of care, not just in a test.