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Medtech Insight
A new template from the US FDA explains what information the agency wants to see in regulating COVID-19 tests to be performed outside the laboratory environment.
Topic Coronavirus FDA Diagnostics
Medtech Insight
The US FDA has authorized marketing of a combination diagnostic that can detect either COVID-19 or influenza. The agency hopes to encourage development of additional similar tests before the fall flu season.
Topic Coronavirus Diagnostics In Vitro Diagnostics Regulation
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