Diagnostics Pipeline: 2024 Trends in FDA Approvals
In vitro diagnostic products approved by the U.S. Food and Drug Administration in 2024 show a continued move toward rapid and point-of-care tests
FDA-dtet
Diagnostics Pipeline: Testing for Intestinal Parasites Takes Step Forward
The EasyScreen assay received 510(k) clearance from the Food and Drug Administration earlier this year–but with a catch
Evolving Regulations and Guidelines in Genetic Testing
Understanding the regulatory landscape of genetic and genomic testing, and its impact on clinical practice
FDA Points the Way to Transition EUA SARS-CoV-2 Tests to Full Approval
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Device Reclassification Order Opens 510(k) Pathway for HCV RNA and Antibodies Tests
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Agency Regains Its Authority to Regulate Laboratory Developed Tests (LDTs)
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FDA Imposes New Limits on COVID-19 Tests with Access to EUA Pathway
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Management Expert Report Cites Weaknesses in Agency’s EUA Processes
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False Positive Recalls Casts Doubt on Rapid COVID Screening Tests at the Worst Possible Time
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FDA Requires EUA SARS-CoV-2 Test Developers to Account for Viral Mutations
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Agency Finalizes Rule on Off-Label Uses Liability and Rights of Laboratories to Create LDTs
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Agency Imposes 2.5 Percent Increase in 2022 Premarket Application User Fees
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FDA Regulation of COVID-19 Testing Enters a New Phase
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