IVD Triage revisions to be considered by FDA task force.
This article was originally published in The Gray Sheet
IVD TRIAGE REVISIONS TO BE CONSIDERED BY FDA TASK FORCE being formed by the Division of Clinical Laboratory Devices in the agency's Office of Device Evaluation. The task force is planning to develop a plan for modifying triage classifications for some in vitro diagnostics, potentially using a proposal submitted by the Health Industry Manufacturers Association as a model. Since FDA advisory committees assisted in the initial triage classifications, the agency likely will ask outside clinicians to assist in the "tier" revisions as well.
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