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 updates reflect changes to standards on medical electrical equipment and a wide range of device types.
The sentences are the latest chapter in a long-running off-label marketing case.