Quote Originally Posted by flerc View Post
I was referring to the test about the product (scolioscore) done by AB. The reliability of course should to be measured by other organization before it could be used.
This type of test falls under a specific category of diagnostic tests that do not require FDA approval. They do, however, have different type of approval that has been given by the government that is specific for clinical labs.

This document explains it.

www.axialbiotech.com/files/fda_approval.pdf