COVID-19: FDA Warns Of Potential Risks Of Antibody Tests
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.
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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.
Device Week, 4 December 2020 – MedWatch Question About Third-Party Servicers Slides Under Industry's Radar
On this week’s podcast: A change made by the US FDA to its MedWatch program that asks adverse event reporters whether a third party serviced a malfunctioning medical device went unnoticed by many in industry for nearly a year. We explain why, and tell how the servicer question will be helpful for manufacturers and the agency.