FDA accepts application for special certification of COVID-19 home test kits | Inquirer News

FDA accepts application for special certification of COVID-19 home test kits

By: - Reporter / @zacariansINQ
/ 09:52 PM January 06, 2022
FDA accepts application for special certification of COVID-19 home test kits

The main office of the Food and Drugs Administration in Muntinlupa City. (Photo from the FDA Facebook page)

MANILA, Philippines — The Philippine Food and Drug Administration (FDA) on Thursday announced it has started accepting applications for special certification of COVID-19 test kits for home use.

This was revealed by FDA officer-in-charge Dr. Oscar Gutierrez during a taped meeting with President Rodrigo Duterte.


“As of today, we announce that we are accepting applications for special certification for COVID-19 self-administered or the home test kit,” he said Gutierrez.

He then called on manufacturers and importers to register with the FDA for the said certification.


“We already met with the DOH ((Department of Health) and they will be coming out with an algorithm, actually a guideline or policy on the use of these home test kits considering these products need to be administered by the patient or the household,” he added.

According to Gutierrez, these guidelines will address how an individual will interpret a test result, how to report a positive case, how to dispose of the waste, and what action should the individual take when they find out that they are positive for COVID-19.

“So we need an algorithm from the DOH, and this will be based on the claims made by the manufacturers. But in general, we need a guideline on this,” he said.

These guidelines will be issued by the DOH by January 17, he added.

Gutierrez likewise said it will depend on the registered products if the self-administered home test kits will be a nasal-type or oral-type kit.


Duque to FDA: Ready approval for at-home use COVID-19 antigen test kits
PH posts 17,220 new COVID-19 cases; positivity rate at 36.9%


For more news about the novel coronavirus click here.
What you need to know about Coronavirus.
For more information on COVID-19, call the DOH Hotline: (02) 86517800 local 1149/1150.

The Inquirer Foundation supports our healthcare frontliners and is still accepting cash donations to be deposited at Banco de Oro (BDO) current account #007960018860 or donate through PayMaya using this link.

Read Next
Don't miss out on the latest news and information.

Subscribe to INQUIRER PLUS to get access to The Philippine Daily Inquirer & other 70+ titles, share up to 5 gadgets, listen to the news, download as early as 4am & share articles on social media. Call 896 6000.

TAGS: at-home use, COVID-19, COVID-19 test kits, FDA
For feedback, complaints, or inquiries, contact us.

Subscribe to our daily newsletter

© Copyright 1997-2022 INQUIRER.net | All Rights Reserved

We use cookies to ensure you get the best experience on our website. By continuing, you are agreeing to our use of cookies. To find out more, please click this link.