investigational device exemption (IDE)

Related concept: inter-rater reliability The degree of stability observed when a measurement is repeated under identical conditions by the same rater. Note: Intra-rater reliability makes it possible to determine the degree to which the results obtained by a measurement procedure can be replicated. Lack of intra-rater reliability may arise from divergences between measurement instruments or instability of the attribute measured.


provide rehabilitation or organize healthcare delivery. Note 1: The intervention can be a test, device, medicine, vaccine, procedure, program or system.»