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    The Changing Clinical Evidence Requirements Under IVDR

    This article discusses the key elements of clinical requirements per the In Vitro Diagnostic Regulation (IVDR) and clinical planning. The IVDR emphasizes the need for manufacturers to demonstrate the clinical evidence for all medical devices. Introduction Whether a company is small or large, the idea of needing a clinical trial to demonstrate device performance can seem daunting. At the CEO level, concerns include cost, time to market and influencing the board of the ma...
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    FDA's Workshop on Troponin Assays Approval Fosters Agreement, Debate

    This article discusses a recent FDA workshop held for troponin assays, tests designed most commonly to detect the release of cardiac troponin following Acute Myocardial Infarction (AMI). The authors review the history, uses and issues associated with using troponin - a three protein complex, released rapidly into the blood after myocardial injury - and innovative medical devices to detect troponin levels, as an assay to aid in the diagnosis of an AMI event. Regulatory pro...