American Association for Clinical Chemistry
Better health through laboratory medicine

A Q&A With the FDA on the RUO/IUO Final Guidance

 

Price: $0.00

Online registration for this event is now closed. If you would like to register for this event, please contact Customer Service (800) 892-1400, Option 2.

Join us for this 60-minute webinar and ask FDA's OIVD Director your questions about how the new RUO/IUO guidance document will affect IVD manufacturers and clinical labs. With the implementation of this document, clinical labs are concerned that: manufacturers may stop selling RUO/IUO reagents; that restricted access to RUO/IUO reagents may stymie the development of new, innovative tests; and that manufacturers may limit sales of RUO/IUO instruments, such as tandem mass spectrometers. Register today and learn which concerns are valid, which are unwarranted, and what you would need to do to be in compliance.