In the current U.S. regulatory environment, clinical evaluation report writing has become a critical component of successful medical device approval strategies. As the FDA continues to emphasize evidence-based decision-making across 510(k), De Novo, and PMA pathways, manufacturers must clearly demonstrate that their devices are safe, effective, and clinically justified. A well-developed Clinical Evaluation Report (CER) not only strengthens FDA submissions but also supports long-term compliance and global market readiness.