FDA Releases COVID-19 Test Performance Data
IVDs from PerkinElmer and Viracor Eurofins were the most sensitive, agency says
The data compares the sensitivity of almost 200 diagnostics against a standardized set of samples.
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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.
The regulatory tools are for use in medical device development.
The focus on innovative manufacturing will also include a new clearinghouse to share info about advanced manufacturing technology within the US agency’s device center.