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FDA Watch: Agency Opens New Pathway for STI At-Home Sample Collection Kits

FDA Watch: Agency Opens New Pathway for STI At-Home Sample Collection Kits

by Glenn S. Demby | Nov 29, 2023 | Essential, FDA-lca, Lab Industry Advisor

With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.

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The Diagnostics Pipeline: FDA Moves to Modernize 510(k) Process for New Lab Tests & Devices

The Diagnostics Pipeline: FDA Moves to Modernize 510(k) Process for New Lab Tests & Devices

by Glenn S. Demby | Oct 30, 2023 | Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

The changes proposed in three new draft guidances aim to speed up the process and place less emphasis on older predicate products.

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FDA Watch: Simplifying and Speeding Up 510(k) Authorization

FDA Watch: Simplifying and Speeding Up 510(k) Authorization

by Glenn S. Demby | Oct 20, 2023 | Essential, FDA-lir, Lab Compliance Advisor, Laboratory Industry Report, National Lab Reporter

What lab leaders need to know about the FDA’s three new 510(k) draft guidances.

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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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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 | Clinical Diagnostics Insider, 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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