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Diagnostic Testing and Emerging Technologies

LAB COMPLIANCE ADVISOR

LABORATORY INDUSTRY REPORT

NATIONAL LAB REPORTER

The Diagnostics Pipeline: Diagnostics Make Up One-Third of Total 2023 Recalls

The Diagnostics Pipeline: Diagnostics Make Up One-Third of Total 2023 Recalls

by Glenn S. Demby | Sep 25, 2023 | Diagnostic Testing and Emerging Technologies, FDA-dtet

With recent test recalls announced by Universal Medtech and QuidelOrtho, such products now make up one-third of 2023 total recalls listed by the FDA.

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Will LDTs Soon Be Regulated?

Will LDTs Soon Be Regulated?

by Rachel Muenz | Sep 6, 2023 | News

The FDA recently submitted its own proposed rule relating to lab-developed test regulation for review.

New CMS Rule Unlikely to Speed Medicare Coverage of Breakthrough Devices

New CMS Rule Unlikely to Speed Medicare Coverage of Breakthrough Devices

by Rachel Muenz | Sep 6, 2023 | News

The recently proposed TCET rule appears to be too stringent to significantly hasten the Medicare coverage process for device makers.

A Successful FDA cGMP Inspection: The Six Steps of a Pre-Inspection Audit

A Successful FDA cGMP Inspection: The Six Steps of a Pre-Inspection Audit

by Glenn S. Demby | Aug 31, 2023 | FDA-lca, Lab Compliance Advisor

Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.

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September 2023 FDA Watch

September 2023 FDA Watch

by Glenn S. Demby | Aug 31, 2023 | FDA-lir, Laboratory Industry Report

More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.

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