IVD PRINCIPAL INVESTIGATORS MUST SIGN OFF ON CLINICAL STUDY DATA
This article was originally published in The Gray Sheet
Executive Summary
IVD PRINCIPAL INVESTIGATORS MUST SIGN OFF ON CLINICAL STUDY DATA used in support of 510(k)s and premarket approval applications for in vitro diagnostic devices, FDA says in a draft "points to consider" document presented Sept. 23 to a joint meeting of the Clinical Chemistry and Toxicology Devices Panel and the Microbiology Devices Panel. The document refers to the procedure as "similar to the requirement of peer-reviewed medical journals."