Full Steam Ahead: FDA Releases Proposed LDT Rule in Advance of Looming Government Shutdown

In a last minute push before an anticipated government shutdown, FDA put down its marker for moving forward toward regulation of lab developed tests (“LDTs”). Unlike past proposals from FDA and Capitol Hill, FDA has taken a simple approach: laboratories that make LDTs for clinical use are manufacturing in vitro diagnostic medical devices (“IVDs”) for commercial distribution, and as such must eventually comply with FDA’s already-established IVD requirements….
By: Epstein Becker & Green