I agree with @gdecarvalho22 above that the FDA indirectly approves the tests as long as the final design and design process shows to comply with FDA standards. If the test parameters are not within what the company claims for either…   Read more»

@gdecarvalho22  You have brought up some good points that transparency of data would lead to a more thorough evaluation and benefit both companies seeking FDA approval and the public but there are potential drawbacks and challenges from this approach.  The…   Read more»