It's about 60 days since a Texas federal court tossed out the FDA LDT regulation. Recall the government had 60 days to file an appeal. If it doesn't, FDA might issue some other kind of information, like an administrator's blog or a press release on the topic.
Along the way, New England Journal has published a 3-page article on the FDA decision. (Spoiler alert - the authors wish the FDA would have won). Find Sachs, Sharfstein & Zettler online here:
https://www.nejm.org/doi/full/10.1056/NEJMp2504926
One lingering question for me, as a non-attorney. The decision clearly means that FDA can't mandate lab-developed procedures to undergo FDA review as devices. But does this also mean the FDA is barred from review of LDTs that labs bring to the FDA voluntarily? A lab might want its LDT to be FDA-approved in order to get some other benefit, like CMS coverage under an NCD or special CMS pricing as an ADLT (advanced diagnostic laboratory test). But could FDA review it, voluntarily, if the FDA is generally precluded from reviewing lab procedures because they are not "devices" and not within FDA scope?
