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GLP Guidance For Waived Testing Accepted; September Publication Planned

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers and distributors should endorse waived testing good laboratory practice guidelines in product information, Clinical Laboratory Improvement Advisory Committee members suggest

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CLIAC Meeting In Brief

CLIA waiver draft guidance: FDA's Clinical Laboratory Improvement Amendment waiver application draft document is consistent with international standards, according to Office of In Vitro Diagnostic Device Evaluation & Safety Director Steve Gutman. The proposed guidance, published in the Sept. 7 Federal Register, was "not intended to reinvent the wheel," Gutman told the Clinical Laboratory Improvement Advisory Committee Sept. 7. For example, he noted that stress studies in the draft reflect ISO risk management practices and current quality system regulations. Additionally, the performance aspect of the proposed guidance is linked to an international standard on traceability. The document is intended to update a 1995 joint CDC/CMS proposed rule for designating CLIA-waived diagnostic tests (1"The Gray Sheet" Sept. 5, 2005, p. 7). Comments on the draft should be sent to the agency before Dec. 6....Gutman encourages comments: Stakeholders should provide both positive and negative feedback during comment periods, Gutman urges CLIAC participants. The agency may get a slanted view of stakeholder opinion in the absence of affirmative comments...

CLIAC Meeting In Brief

CLIA waiver draft guidance: FDA's Clinical Laboratory Improvement Amendment waiver application draft document is consistent with international standards, according to Office of In Vitro Diagnostic Device Evaluation & Safety Director Steve Gutman. The proposed guidance, published in the Sept. 7 Federal Register, was "not intended to reinvent the wheel," Gutman told the Clinical Laboratory Improvement Advisory Committee Sept. 7. For example, he noted that stress studies in the draft reflect ISO risk management practices and current quality system regulations. Additionally, the performance aspect of the proposed guidance is linked to an international standard on traceability. The document is intended to update a 1995 joint CDC/CMS proposed rule for designating CLIA-waived diagnostic tests (1"The Gray Sheet" Sept. 5, 2005, p. 7). Comments on the draft should be sent to the agency before Dec. 6....Gutman encourages comments: Stakeholders should provide both positive and negative feedback during comment periods, Gutman urges CLIAC participants. The agency may get a slanted view of stakeholder opinion in the absence of affirmative comments...

CLIA-Waived Test Market Increasing As Public Health Concerns Loom

Rapid growth in the adoption of CLIA-waived laboratory tests is causing some unease regarding appropriate use of the tests

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