IVD vs. RUO-Is Your Laboratory Relying on the Right Products?

What you need to know to protect patients and your laboratory.
Webinar presenter Sebastian Gromminger, PhD, Strategic Expert in the field of in-vitro diagnostics with a focus on molecular genetic diagnostics and consultant for the approval of in-vitro diagnostics, Johner Institut GmbH, discusses what the “Research Use Only” (RUO) label means and its consequences for medical laboratories, manufacturers, and patients; how the definition of RUO differs in the US and EU; the implications of manufacturers and medical laboratories using RUO labelled products; what RUO products should be used for vs. what RUO products are typically misused for; how IVD requirements compare to RUO; and the importance of choosing IVD over RUO third-party quality controls for medical laboratories.
Moderated by: Bob McGonnagle, Publisher, CAP TODAY.
This on-demand webinar originally broadcast March 28, 2023.
CAP TODAY does not endorse any of the products or services named within. The webinar is made possible by a special educational grant from Microbiologics.