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.
Cutting Edge Dx Approvals Threaten FDA’s Fuddy-Duddy Reputation
From - National Intelligence Report
A trio of recent FDA product approvals in the diagnostics space have belied the agency's traditional reputation for resisting medical innovation. Here's the timeline for…
FDA Approves First NGS Oncology Companion Dx for Multiple Therapies
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FDA Speeding Approval Process, Continued User Fees Needed
From - National Intelligence Report
The U.S. Food and Drug Administration (FDA) has been chronically plagued with understaffing, an ever expanding workload and…
FDA Sends 14 Warning Letters Regarding Cancer Products
From - National Intelligence Report
The U.S. Food and Drug Administration (FDA) continues to focus on direct-to-consumer marketing and sale of products and has issued warning letters in an effort to…
FDA Exempts Certain Class I Devices, Test Kits from 510(k) Filing
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FDA Reports Advances in Diagnostics Development
From - National Intelligence Report
The U.S. Food and Drug Administration (FDA) recently unveiled its FY 2015-2016: Regulatory Science Progress Report. The report, the second of its kind under the Food and Drug Administration Safety and Innovation Act, says the…
23andMe Receives FDA Approval for DTC Genetic Test
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FDA Reports “Significant Progress” in Diagnostics Development
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Reports Indicate Faster FDA Approval Processes
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Test Kits Included in Class 1 Devices Exempt from 510k Filing
From - National Intelligence Report
The FDA has determined that 71 device types, including some diagnostic test kits, should be exempt from 510k filings. These devices are deemed "sufficiently well understood and do not present risks that…
