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 Watch: Natera, Valar Labs Receive FDA Clearances for Bladder Cancer Tests
Natera’s assay focuses on the need for adjuvant therapy, while Valar’s test stratifies risk of recurrence
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FDA Watch: New RAPID Coverage Pathway Would Enable Some Lab Tests to Pursue Clearance and Medicare Coverage Simultaneously
FDA-CMS collaboration aims to accelerate Medicare coverage determinations of certain medical devices
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A New Tool for Helping Labs Improve Diversity in Clinical Trials
Rachel Rangel, AuD, discusses a new toolkit to help laboratory professionals ensure diversity and inclusion is addressed in their research.
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FDA: EUAs for COVID-19 Lab Tests Will Continue after PHE Ends
Agency says it will continue to have authority to clear new lab tests and other COVID-19 products on an emergency basis even after the PHE ends.
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Empowered Dx in Hot Water with FDA Again Over COVID-19 Test Kits
At the end of 2022, the agency sent a new warning letter to Empowered for unauthorized distribution of COVID-19 test kits.
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FDA Tightens the Screws on EUA Review of COVID-19 Tests
The agency recently announced subtle but significant changes to its policies governing review of new lab tests for COVID-19.
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FDA to Issue Emergency Use Authorization for Monkeypox Tests
In a move to expand access to lab testing for monkeypox, HHS has authorized the FDA to issue EUAs for in vitro diagnostic tests for the virus.
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FDA Sounds the Alarm on Counterfeit OTC COVID-19 Tests
Counterfeit COVID-19 tests are being illegally imported into the US and being distributed to unsuspecting consumers across the country.
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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