In Brief: IVD Triage
This article was originally published in The Gray Sheet
Executive Summary
IVD Triage: Additions to FDA's Tier I category of in vitro diagnostics scheduled to take effect June 1, according to FDA's Division of Clinical Laboratory Devices. The agency says that as a result of the triage process, the number of Tier I IVDs, which receive a simplified, administrative review, has been increased by 20% in the Clinical Chemistry Branch, 20% in the Microbiology Branch, and 14% in the Immunology Branch. There is no change in the number of Tier I IVDs in the Hematology Branch. FDA gathered input from the public, industry and healthcare professionals on its triage process at an Oct. 30 workshop in Rockville, Maryland ("The Gray Sheet" Nov. 6, 1995, p. 8)...
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