In Vitro Diagnostic (IVD) devices play a crucial role in healthcare by providing valuable information for disease diagnosis, patient monitoring, and treatment decisions. The European Union's In Vitro Diagnostic Regulation (IVDR) 2017/746 introduced a new classification system for IVDs.
The US Food and Drug Administration (FDA) defines Clinical Outcome Assessment (COA) as a narration and reflection of how a person feels, functions or survives. The medical device manufacturers may opt to include Clinical Outcome Assessments (COA) in the Regulatory submissions for their device approvals such as PMA and 510(k). Well planned, structured and reported clinical outcome measures provide quality information to demonstrate benefit-risk aspects of a medical device, frame labeling communications, defining patient selection criteria for clinical studies and measurement criteria.
