Ann: Lumos Receives US FDA Clearance for FebriDx, page-390

How do you think they show substantial equivalence? No validation data? No safety data? No international standards or FDA produced standards? What do you think FDA reviews in a 3 month 510k clearance timeline? Why is there often a 3000+ submission for a 510k? How many subject matter experts in the FDA do you think that gets sent off to for review, so it can be completed in 3 months?

A PMA is for a class 3 high risk device. yes, the FDA review the crap out of it because it will literally kill patients if things go slightly wrong. The 510k process is for class 2 devices which are of medium to low risk and as such the requirements are less rigid but it is completely wrong to state the FDA do not review its safety or effectiveness. These two terms are the basis for all FDA 510k clearances. That is also the basis of the predicate system.

Have a look at the why the first application was rejected. It was for false negative results which could lead to slow treatment of patients and thus increase risk for patients. That was obviously identified with performance data which was provided as part of the submission.