### Comment:
&gt;“Easy”  
  
 The real loophole is the “Letter to File” pathway where you can sell stuff without any testing. You just need to have documentation internally to support the device until the day the FDA disagrees with it

### REPLY:
Yeah its real easy to get anything FDA cleared, not neccesarily FDA approved. [John Oliver just talked about medical devices and FDA cleared.](https://www.youtube.com/watch?v=-tIdzNlExrw)

### END.