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HOME-USE PROTHROMBIN DIAGNOSTICS WOULD REQUIRE CLINICAL TRIALS

This article was originally published in The Tan Sheet

Executive Summary

HOME-USE PROTHROMBIN DIAGNOSTICS WOULD REQUIRE CLINICAL TRIALS at a minimum of three sites studying normal patients and patients with "different hematologic profiles," Djuana Blagmon of FDA's Division of Clinical Laboratory Devices told an Aug. 5 meeting of the agency's Hematology and Pathology Devices Advisory Panel. The panel discussed the feasibility, safety and effectiveness of home- use prothrombin time tests. The tests are currently used only in professional settings, but FDAers said manufacturers have expressed interest in marketing home-use versions and have inquired about FDA's submission policy.
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