FDA Watch: OraSure’s Collection Device for Cobas STI Testing Receives Approval
At-home sample collections can be mailed to a clinical laboratory
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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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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…
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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…
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Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory
Gottlieb Resigns as FDA Chief: Lab Industry Loses a Good Frenemy
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FDA Watch: Latest Plan to Simplify 510(k) Premarket Review of New Tests
From – National Intelligence Report
While everybody agrees that the FDA 510(k) premarket review pathway is antiquated and in desperate need of an overhaul…
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Genetic Testing: 23andMe Gets FDA Clearance for Direct-to-Consumer Marketing of Personal Genome Service
From – National Intelligence Report
The FDA is allowing direct-to-consumer marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test for genetic variants to detect…
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LDTs: FDA Announces New Approach to 510(k) Approvals
From – National Intelligence Report
Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including…
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FDA Watch: Agency Approves New Flu Tests and Drug
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