FDA Watch: MeMed and NG Biotech Receive FDA Breakthrough Device Designations for Rapid Infection Tests
In both cases, the diagnostic tests report results back within 15 minutes
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ADLM Calls on Feds to Regulate AI in the Clinical Lab Sector
But anti-regulatory stance taken by Trump administration could serve as a potential obstacle in the effort
FDA Watch: Truvian Health Obtains 10 Additional FDA Clearances for TruVerus Platform
TruVerus is designed to perform a slew of clinical laboratory tests on as few as eight drops of blood
Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
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FDA Targets Sale of IVD Reagents without Premarket Approval
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FDA Resounds the Alarm on Biotin Test Interference
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New Product Development: FDA Issues Final Guidance on IVD Oncology Trials
On Oct. 10, 2019, the FDA finalized guidance on an optional streamlined submission process to determine whether
LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims
From - National Intelligence Report
The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict…
Inside Washington: What’s Going on with Regulation of LDTs?
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New FDA Guidance Tells IVD Makers How to Test for Biotin Interference
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FDA Watch: Agency Okays Marketing of Zika Test for First Time
From - National Intelligence Report
Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different…
Case of the Month: FDA Issues Warning Letter for Unapproved Changes to Approved Assay
From - National Intelligence Report
As a rule of thumb, FDA approvals are a snapshot applicable only to the product as it exists at the time of review and approval…
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory