COVID-19: Fingerstick Serology EUA Template Tweaked By FDA
The US agency has updated its emergency use authorization template for developers making home-use coronavirus serology tests that use fingersticks to collect blood samples.
You may also be interested in...
The US FDA issued a new template for serology test-makers that detect or correlate to neutralizing antibodies, and also updated an existing template to reflect concerns over viral mutations
The agency published a supplemental template for molecular and antigen COVID-19 EUA sponsors whose product can be used for serial testing, and a fact sheet that screening program organizers can use to pick the right test.
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?