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How U.S. and EU Decisions Are Reshaping Your Market Strategy by David Petrich and Pieter Bogaert If you're developing in vitro diagnostics (IVDs) for global markets, you just experienced one of the most volatile regulatory years in a decade. In the U.S., a federal court overturned the FDA's proposed oversight of Lab-Developed Tests (LDTs). In Europe, regulators moved in the opposite direction, tightening requirements for In-House Devices (IHDs). For startups, manufacturers, a