EXPANDED IVD TIER I LIST BASED ON NCCLS STANDARDS ENDORSED BY FDA; WORKSHOP PANELISTS OPPOSE ADDING POINT-OF-CARE, PHYSICIAN-OFFICE TESTS TO TIER I
This article was originally published in The Gray Sheet
FDA may be willing to move more in vitro diagnostics into the least stringent premarket review "tier" (Tier I) if the National Committee for Clinical Laboratory Standards develops review criteria for the products, Steve Gutman, director of the device center's Division of Clinical Laboratory Devices (DCLD) said at an Oct. 30 workshop in Rockville, Maryland.
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