It looks like Lab Developed Tests for diagnostics are back on the table in the US?!?

 

For an old post on what a Lab Developed Test (LDT) is vs an In Vitro Diagnostic (IVD) you can go here. 

And...in what was an altogether extremely bad day for the FDA with thousands of people finding out when they tried to use their badges and they simply didn't work - they also lost a federal appeal in this recent ruling.

The American Clinical Lab Association sued to overturn FDA's new rules for moving all new (?) or all (?) diagnostics to IVD designation. So....for those of us who put Aim 4 of our grants things like "and then we'll move this to an FDA approved medical device LCMS system..." we don't have to come up with something more clever to write for how to translate our findings. 

To the thousands of HHS/NIH/FDA employees who just found out they were cut by a heartless and misinformed administration, I'm sorry and I hope you can continue making the world a better place in a better role for yourselves.