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Design History File (DHF) deficiencies remain one of the most common causes of FDA Form 483 observations for IVD and medical device manufacturers. This article highlights seven critical DHF gaps frequently identified during FDA inspections, explains why they occur, and outlines practical steps to strengthen traceability, design controls, and inspection readiness before regulatory issues arise.

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