FDA Watch: CND Life Sciences Wins Breakthrough Device Designation for Skin-Based Neurodegenerative Test
The Syn-One assay can diagnose multiple conditions without needing a lumbar puncture
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Chevron Doctrine’s Dismissal Has Yet to Upend Regulatory Environment
However, clinical laboratories may have more say in future laws and guidance thanks to 2024 decision
FDA Watch: Mass Spectrometry Test Receives First Moderate Complexity Designation
Roche’s vitamin D assay includes internal quality controls that allowed it to obtain the CLIA designation
FDA Pulls the Plug on EUA Review of COVID-19 LDTs
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Agency Stripped of Authority to Issue Premarket Approval of SARS-CoV-2 LDTs
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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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