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Zdrowie i gospodarka · 31.07.2017

Cardiac Troponin Assays; Public Workshop; Request for Comments

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled "Cardiac Troponin Assays." The purpose of the workshop is to discuss the development of innovative troponin assays designed to aid in the diagnosis of myocardial infarction (MI) and additional clinical uses of these assays. The workshop is intended to enhance engagement with stakeholders to facilitate device development and to discuss scientific and regulatory challenges associated with the analytical and clinical validation methods for troponin assay devices. Public input and feedback gained through this workshop may aid in the development of science-based approaches to aid in the efficient development of innovative, safe and effective, troponin diagnostic assays, which may lead to better patient care.

Source: Federal Register — Food and Drug AdministrationOpen original release →