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Which Recent FDA Webinars Are Most Useful for the LDT Rule?

Which Recent FDA Webinars Are Most Useful for the LDT Rule?

by Tara Cepull, MA | Jan 22, 2025 | Compliance Perspectives-lca, Essential, FDA-lca, Lab Industry Advisor

Regulatory expert Julie Ballard shares her thoughts on the most useful resources for labs as they get ready to comply with Stage 1

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FDA Watch: How Could the Change in US Government Affect IVDs and Labs?

FDA Watch: How Could the Change in US Government Affect IVDs and Labs?

by Rachel Muenz | Jan 6, 2025 | Essential, FDA-lir, Lab Industry Advisor

Experts say new leadership could impact the cost and availability of IVDs as well as patients’ ability to afford lab testing

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Diagnostics Pipeline: Testing for Intestinal Parasites Takes Step Forward

Diagnostics Pipeline: Testing for Intestinal Parasites Takes Step Forward

by Ron Shinkman | Nov 25, 2024 | Clinical Diagnostics Insider, FDA-dtet

The EasyScreen assay received 510(k) clearance from the Food and Drug Administration earlier this year–but with a catch

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Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule

Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule

by Rachel Muenz | Nov 21, 2024 | Compliance Perspectives-lca, FDA-lca, Lab Industry Advisor, Premium

Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule

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How the LDT Final Rule’s Exemptions Apply to Oncology Labs

How the LDT Final Rule’s Exemptions Apply to Oncology Labs

by Scott Wallask | Nov 7, 2024 | Compliance Perspectives-lca, Compliance-lca, Essential, FDA-lca, Lab Industry Advisor

Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines

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