Repeat At-Home COVID-19 Antigen Tests to Avoid False Negatives, FDA Says
The agency is advising people to perform repeat, or serial testing after a negative result, regardless of symptoms.
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GAO: FDA Needs Policy to Avoid Repeating EUA COVID-19 Test Mistakes
In a recent report, the GAO says the agency needs a policy when it comes to enforcement discretion regarding tests approved via EUA.
FDA Re-Opens Door to Pre-Submission Requests for Non-COVID-19 IVD Tests
The move comes shortly after the FDA said it was going to decline some pre-submission requests to focus on pandemic-related diagnostics.
Medical Device User Fees Agreement Finally Nearing the Finish Line
Though it took longer than expected, the medtech industry and FDA have finally agreed on medical device user fees for the next five years.
FDA Lays Out New Guidelines for Medical Device Cybersecurity
With cyberattacks becoming increasingly common, the FDA has issued long-awaited draft guidance to help device makers deal with the threat.
InspectIR Nabs First FDA Approval for a SARS-CoV-2 Breathalyzer
On April 14, the FDA announced that, for the first time, it has granted Emergency Use Authorization for a COVID-19 breathalyzer test.
New Deal Reached for MDUFA Medical Device User Fees
The FDA’s Center for Devices and Radiological Health says that the agency and industry have reached agreement on MDUFA V.
2021 Was a Breakthrough Year for Breakthrough Devices Program
The FDA designated 213 submissions as breakthrough devices in 2021, the most awarded in a single year, by far.
Agency Continues Crack Down on Unauthorized COVID-19 Tests
On Jan. 11, the FDA warned consumers not to use COVID-19 tests from LuSys Laboratories, as they have not been approved for use in the US.
