MeMed Sepsis Test Gains Breakthrough Device Designation
The 15-minute assay to detect sepsis and assess its severity and risk is expected to get full FDA approval by 2026
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Which Recent FDA Webinars Are Most Useful for the LDT Rule?
Regulatory expert Julie Ballard shares her thoughts on the most useful resources for labs as they get ready to comply with Stage 1
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
FDA Cracks Down on Improper Marketing of SARS-CoV-2 Antibody Tests
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Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
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Lab Companies Scramble to Bring Coronavirus Detection Tests to Market
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FDA Extends Deadline to Comment on Proposed 510(k) Pathway Reform
From - Lab Compliance Advisor
April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for…
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
From DAIA to the VALID ACT: The Latest Chapter in FDA Diagnostic Test Oversight Reform
From - Lab Compliance Advisor
While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the…
Government Shutdown: The Impact on the Agencies that Regulate Labs
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FDA Warns About Biotin Interference With Lab Tests
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CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency
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