Emergency use authority not needed for home test kit – FDA

Emergency use authority not needed for home test kit – FDA
Sheila Crisostomo
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Emergency use authority not needed for home test kit – FDA
MANILA, Philippines — The emergency use authorization (EUA) recently approved by President Duterte applies only to vaccines and medicines against COVID-19 and is not necessary for test kits, which only need a special certificate, an official of the Food and Drug Administration (FDA) said yesterday.
FDA director general Eric Domingo explained that the EUA is needed for vaccines and medicines used for COVID-19, but the medical devices, such as the Elluma home testing kits, would only need to apply for a special certificate from the agency.

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