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CLIA Waiver Withdrawal Option Likely Will Be Explored By CDC Subcommittee

This article was originally published in The Gray Sheet

Executive Summary

The possibility of recommending a process whereby CLIA waivers can be withdrawn for certain in vitro diagnostic tests will be examined by a workgroup of CDC's Clinical Laboratory Improvement Advisory Committee

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CLIA Waiver Sign-Off May Return To FDA – OIVD’s St. Pierre

HHS may decide by Nov. 1 whether to shift the delegation authority for CLIA waivers to FDA, OIVD Deputy Director for New Device Evaluation Donald St. Pierre stated at the Regulatory Affairs Professionals Society's annual conference in Baltimore Oct. 22

CLIA Waiver Sign-Off May Return To FDA – OIVD’s St. Pierre

HHS may decide by Nov. 1 whether to shift the delegation authority for CLIA waivers to FDA, OIVD Deputy Director for New Device Evaluation Donald St. Pierre stated at the Regulatory Affairs Professionals Society's annual conference in Baltimore Oct. 22

CLIAC

Proposals for a new CLIA waiver workgroup to devise procedures for rescinding CLIA waivers are unnecessary FDA requirements regarding labeling already provide sufficient safeguards for CLIA-waived products, AdvaMed reps maintain following Sept. 17 CLIAC meeting comments on the topic (1"The Gray Sheet" Sept. 22, 2003, p. 16). At the meeting, CLIAC decided to establish the waiver workgroup to flesh out CLIA waiver policy. AdvaMed will be represented in the workgroup by CLIAC industry rep Luann Ochs, Roche Diagnostics...

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