FDA Watch: Zepto Life Technology Receives FDA Breakthrough Designation for Blood-Based Mold Test
Its FungiFlex assay can make determining the cause of fungal infections vastly more accurate
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New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA
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FDA Watch: Natera, Valar Labs Receive FDA Clearances for Bladder Cancer Tests
Natera’s assay focuses on the need for adjuvant therapy, while Valar’s test stratifies risk of recurrence
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Congress Retables VALID and VITAL Legislation to Regulate LDTs
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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…
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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…
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Government Shutdown: The Impact on the Agencies that Regulate Labs
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