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FDA CLEARANCE OF BTA STAT FOR PRESCRIPTION HOME USE WOULD EXPAND BARD'S PHYSICIAN MARKET VIA CLIA-WAIVED STATUS; PANEL SUGGESTS SIMPLIFYING LABELING

This article was originally published in The Gray Sheet

Executive Summary

FDA approval of Bard's BTA stat bladder cancer tumor marker assay as a "waived" test under the Clinical Laboratory Improvement Amendments of 1988 would allow greater distribution of the product by opening up the broader physician office market. The agency's Immunology Devices Panel, at its Feb. 2 meeting in Rockville, Maryland, supported prescription home use labeling for the test provided that specific changes designed to simplify the labeling are made.
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