Zdrowie i gospodarka · 08/10/1999

Medical Devices: Draft Guidance on Premarket Approval Applications for Assays Pertaining to Hepatitis C Viruses (HCV) That Are Indicated for Diagnosis or Monitoring of HCV Infection or Associated Disease; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance on Premarket Approval Applications for Assays Pertaining to Hepatitis C Viruses (HCV) That Are Indicated for Diagnosis or Monitoring of HCV Infection or Associated Disease.'' This draft guidance is intended to provide current insights on the design, data collection, and data analysis of studies that are important to the premarket approval application (PMA) approval process for in vitro diagnostic (IVD) devices pertaining to HCV. This draft guidance document represents the agency's current thinking regarding PMA's for IVD devices that pertain to HCV infection. This draft guidance is neither final nor is it in effect at this time.