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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FDA Exempts Certain Class I Devices, Test Kits from 510(k) Filing
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FDA Reports Advances in Diagnostics Development
From – National Intelligence Report
The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the Food and Drug Administration Safety and Innovation Act, says the…
23andMe Receives FDA Approval for DTC Genetic Test
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FDA Reports “Significant Progress” in Diagnostics Development
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Reports Indicate Faster FDA Approval Processes
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Test Kits Included in Class 1 Devices Exempt from 510k Filing
From – National Intelligence Report
The FDA has determined that 71 device types, including some diagnostic test kits, should be exempt from 510k filings. These devices are deemed “sufficiently well understood and do not present risks that…
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FDA Grants Approval for 23andMe DTC Genetic Test
From – National Intelligence Report
23andMe and the U.S. Food and Drug Administration (FDA) announced last week that the agency allowed marketing of 23andMe’s Personal Genome Service Genetic Health Risk (GHR) tests for…
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Flu Antigen Tests Reclassified as Class II Devices
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FDA Discussion Paper Synthesizes Stakeholder Feedback on LDT Regulation
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FDA Synthesizes Feedback on LDTs in New Discussion Paper
From – National Intelligence Report
Following up its decision not to issue final guidance in 2016 regarding oversight of laboratory developed tests (LDTs), the U.S. Food and Drug Administration released a…
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