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FDA Watch: What Labs Need to Know About New Medical Device Cybersecurity Rules

FDA Watch: What Labs Need to Know About New Medical Device Cybersecurity Rules

by Glenn S. Demby | Sep 29, 2023 | Essential, FDA-lir, Lab Compliance Advisor, Laboratory Industry Report, National Lab Reporter

As of October 1, medical device makers must include information about their products’ vulnerabilities when seeking premarket authorization.

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September 2023 FDA Watch

September 2023 FDA Watch

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

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

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August 2023 FDA Watch

August 2023 FDA Watch

by Glenn S. Demby | Aug 1, 2023 | Essential, FDA-lir, Laboratory Industry Report

Centers for Medicare & Medicaid Services proposes TCET pathway to expedite Medicare Coverage of newly approved breakthrough devices.

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The Diagnostics Pipeline: FDA Launches Pilot for Cancer Companion Diagnostic LDTs

The Diagnostics Pipeline: FDA Launches Pilot for Cancer Companion Diagnostic LDTs

by Glenn S. Demby | Jul 31, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

New program aims to provide greater transparency on the recommended performance characteristics of such tests.

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July 2023 FDA Watch

July 2023 FDA Watch

by Glenn S. Demby | Jul 5, 2023 | Essential, FDA-lir, Laboratory Industry Report

Key approvals announced in June represented important steps forward for the lab testing industry.

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