FDA Releases New Tools to Speed COVID-19 Test Development
The US agency on 29 May gave two additional tools to COVID-19 test developers: an emergency use authorization template for tests using at-home sample collection kits, and a reference panel for the disease.
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The US agency has authorized the first COVID-19 test to use at-home saliva sample collection. Rutgers Clinical Genomics Laboratory landed the emergency use authorization.
Manufacturers faced with an increasingly complex landscape of state patient-privacy laws may opt to comply with federal Health Insurance Portability and Accountability Act regulations instead, attorney Brad Rostolsky tells Medtech Insight.