FDA prepared this comprehensive document as a resource for you and for its own staff to address issues concerning IVD studies. This guidance document contains information relevant to studies conducted during the development of a new IVD product, as well as other general considerations about applicable requirements and marketing of the new device. It addresses particularly those investigational studies that are exempt from the majority of requirements under 21 CFR Part 812. IVD study investigators and members of IRBs who review and approve such studies may also find it helpful. The use of investigational IVD devices in clinical studies designed to evaluate new drug products falls outside the scope of this guidance.
