FDA Watch: EU’s New IVD Regulations Could Drive More Firms to Seek FDA Approval
Although the timelines have been extended several times, IVDR complexity has created a concerning bottleneck in the approval process
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Diagnostics Pipeline: Testing for Intestinal Parasites Takes Step Forward
The EasyScreen assay received 510(k) clearance from the Food and Drug Administration earlier this year–but with a catch
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Evolving Regulations and Guidelines in Genetic Testing
Understanding the regulatory landscape of genetic and genomic testing, and its impact on clinical practice
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Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
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
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
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