FDA Watch: Agency Restructures Submission Protocols for Several ISH Tests
The FDA is reclassifying product codes NYQ, MVD, OWE, and PNK so they can be approved using the 510(k) submission process
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FDA Watch: Labcorp Gets Companion Diagnostic Approval for Advanced Melanoma Test
Company also announces distribution of newly approved Alzheimer’s assay
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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 Sounds the Warning on Use of Unauthorized SARS-CoV-2 Rapid Tests
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Don’t Use These Rapid COVID-19 Tests, FDA Warns
The US Food and Drug Administration recently issued a letter warning people not to use two different tests produced by Empowered Diagnostics.
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FDA Lists 27 Current COVID-19 Tests that May Not Detect Omicron
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HHS Reinstates FDA Premarket Review of LDTs
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FDA Expands Recall of Ellume COVID-19 Home Test Kits
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FDA Targets High Throughput COVID-19 Tests for Recall Due to Risks of False Positives
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FDA Hikes Premarket Application User Fees by 2.5 Percent
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FDA Hikes Premarket Application User Fees by 2.5 Percent
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FDA Clears the Way for Over-the-Counter Sale of COVID-19 Home Test Kits
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