COVID-19: FDA Warns Of Potential Risks Of Antibody Tests
Executive Summary
The US agency’s decision to allow developers to distribute tests that detect COVID-19 in human blood without going through a clearance process has led to some misleading marketing, the agency warned in two recent statements.
You may also be interested in...
COVID-19: FDA Anticipates Further Serology Test Development
US FDA staff discussed hopes for additional serology and saliva tests for COVID-19, as well as at-home test options, during a 15 April webinar.
Ready, Set, Go: ‘Unprecedented’ FDA Guidance Aims To Unburden Coronavirus Test Makers, Speed Process
The US agency issued a guidance document that significantly lowers regulation of diagnostics used specifically to fight the ongoing COVID-19 pandemic. The new policies give states far more autonomy, allow diagnostics makers to distribute products before an Emergency Use Authorization is issued by the FDA, and permits certain serological tests on the market if they adhere to proper labeling.
New Warning Label Added To AFX2 Endovascular Graft
The US FDA released updated safety information on Endologix Inc.’s AFX2 Endovascular abdominal aortic aneurysm (AAA) graft system on Tuesday. Previous devices in the product line have been associated with an increased risk of abnormal bleeding.