March 18, 2021

Does the FDA ever disagree with the Third Party recommendation?

Let us assume for a moment that Nanox were not a fraud and the Third Party did indeed recommend SE on December 28, 2020.  Is it possible that the FDA disagrees and issues an NSE decision anyway?

The FDA's "Third Party Review Organization Performance Report" that comes out each quarter can be very useful for answering such a question.  The latest one has this nice table.



Turns out, it is not very likely, but it is possible.  Of the 75-85 submissions each year, the FDA disagrees in 1 or 2 cases.  Between 5 and 10 submissions are withdrawn or deleted (basically, the submitter gives up).  Interestingly, no Third Party seems to make an NSE recommendation - I guess that's why they are paid the big bucks by the submitters.

Update April 5, 2021:  Nanox beat the odds and got clearance for a Nanox.Cart (the ugly device).

1 comment: