CLIA '88 "waiver" statistical data recommendations too burdensome, J&J's Lasky says.
This article was originally published in The Gray Sheet
CLIA '88: IVD "WAIVER" REQUEST STATISTICAL DATA RECOMMENDATIONS outlined by the Centers for Disease Control and Prevention could prove overly burdensome for in vitro diagnostics manufacturers, Fred Lasky, director of government and regulatory affairs, Johnson & Johnson Clinical Diagnostics, suggested May 10 at a Clinical Laboratory Improvement Advisory Committee meeting in Atlanta. Lasky, the industry representative on the committee, specifically raised concern about the recommendation that "when possible, statistical data (including raw data) should be submitted" with a manufacturer's request that its IVD be placed in the "waived" category under the Clinical Laboratory Improvement Amendments of 1988.
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