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Medtech Insight

FDA Boosts Development Of OTC COVID-19 Tests With New Template

FDA Boosts Development Of OTC COVID-19 Tests With New Template

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

FDA Clears CDC Diagnostic For COVID-19 And Influenza

mti-FDA-Clears-CDC

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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