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U.S. FDA Announces eSTAR Pilot Program to Streamline 510(k) Submission Process

On February 27, 2020, the U.S. Food and Drug Administration (FDA) announced the launch of its new pilot program for 510(k) submission templates.

Diagnostic Developers Look to EUA Submission to Combat Novel Coronavirus (COVID-19)

China initiated its highest level of emergency response to the COVID-19 outbreak (also referred to as the novel Coronavirus) on 20 January 2020.