Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the “Agency’s”) controversial rule that ended its longstanding policy of enforcement discretion for laboratory-developed tests, or “LDTs,” purporting to regulate them as “devices” under the Food, Drug, and Cosmetics Act (the “FDCA”) (the “LDT Rule” or the “Rule”). While this is a clear win for companies in the diagnostic and lab services space, we are now left wondering – is there any path forward for the LDT Rule? It’s not looking too likely but, these days, anything could happen.

Continue Reading LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court