COVID-19 Serology Templates: FDA Updates Sponsor Template, Adds Home Test Document
The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.
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The US agency on 23 September granted emergency use authorization for the Assure COVID-19 IgG/IgM Rapid Test Device to be used in point-of-care settings like doctor’s offices, hospitals, urgent care centers and emergency rooms. The test requires a fingerstick to draw blood.
The US HHS was responsible for the most major regulations over the last few years of any agency, an OMB report shows.
If approved, the device will be the first drug-coated balloon indicated specifically for use in arteries below the knee.