Business Multiplex

1. New Draft Guidance for Multiplex Tests Elizabeth Mansfield and Michele Schoonmaker Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) CDRH/FDA 2. Notice…

Documents FDA Regulation of In Vitro Diagnostic Tests FDA Regulation of In Vitro Diagnostic Tests FDA Public.....

Slide 1 FDA Regulation of In Vitro Diagnostic Tests FDA Regulation of In Vitro Diagnostic Tests FDA Public Meeting on Oversight of Laboratory Developed Tests July 19 –…

Documents New Draft Guidance for Multiplex Tests Elizabeth Mansfield and Michele Schoonmaker Office of In...

New Draft Guidance for Multiplex Tests Elizabeth Mansfield and Michele Schoonmaker Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) CDRH/FDA Notice of Availability…