Biochemical
and Bioimaging Endpoints in Cardiocerebrovascular Diagnosis,
Prevention, Therapy and Drug Development
GLOSSARY
To
facilitate the dialogue among the multidisciplinary scientists,
definition of the acronyms and of more specialized terms have been
reported.
Every amendment is welcome.
By: Andrea P. Peracino
Stefano Bellosta
Nicola Ferri
Riccardo Roggeri
FDA’s primary consideration in determining when a new IVD requires a PMA is the level of risk to patient health that information obtained from use of the IVD may have in the event of an erroneous test result. In this context, FDA seeks to understand whether the proposed new IVD will be used in a manner that will uniquely and substantively affect diagnostic or therapeutic interventions for a particular disease or condition
