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.
FDA Watch: Latest Plan to Simplify 510(k) Premarket Review of New Tests
From - National Intelligence Report
While everybody agrees that the FDA 510(k) premarket review pathway is antiquated and in desperate need of an overhaul…
Genetic Testing: 23andMe Gets FDA Clearance for Direct-to-Consumer Marketing of Personal Genome Service
From - National Intelligence Report
The FDA is allowing direct-to-consumer marketing, with special controls, of the 23andMe Personal Genome Service Pharmacogenetic Reports test for genetic variants to detect…
LDTs: FDA Announces New Approach to 510(k) Approvals
From - National Intelligence Report
Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including…
FDA Watch: Agency Approves New Flu Tests and Drug
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FDA Biological Products Agency Issues New Recommendations for Emergency Weather Response
From - National Intelligence Report
With another hurricane season wreaking havoc, the FDA's Center for Biologics Evaluation and Research (CBER), which regulates…
LDTs: FDA Does an End Run on Regulatory Proposal Lab Industry Helped Create
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New Zika Blood Testing Guidance Effective Immediately
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FDA Says LOINC Coding of IVD Tests Is Voluntary, Not Mandatory
From - National Intelligence Report
On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four…
FDA Opens Door to Direct-to-Consumer Marketing of Genetic Tests—But Just a Crack
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Genomic Tests: Two New Assays Win FDA Breakthrough Device Designation
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