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.
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.
CMS to Cover Hepatitis C Screening In Eligible Adults
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Combination Product Groups Calls For New FDA Policy on IVDs, LDTs
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LDT Guidance Unlikely to Be Released Anytime Soon
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FDA to Review 23andMe 510(k) for Rare Syndrome
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Senators Request Release of FDA Lab Test Guidance
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Debate Continues Over FDA Regulation of LDTs
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Colon Cancer Screening Test Gets FDA Approval, Proposed Medicare Coverage
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FDA Plans to Regulate Lab-Developed Tests Could Increase Time and Cost of Development
In its July 31 notice to Congress, the agency says it would phase in oversight requirements over nine years.
FDA Official Defends Plan to Issue Guidance for LDTs
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