FDA begins accepting applications for special certifications for COVID-19 home test kits
The Food and Drug Administration (FDA) has begun to accept applications for special certification for COVID-19 self-administered or home test kits due to the increasing number of cases.
"As of today, we announce that we are accepting applications for special certification for COVID-19 self-administered or the home test kits," FDA OIC Director General Oscar Gutierrez Jr. said during the Talk To The People with President Rodrigo Duterte on Thursday night.
"So I am calling all the manufacturers and even the importers of self-administered COVID-19 test kits, to register their product in a form of special certification," he said.
"It can be oral. It depends. We are waiting for the manufacturers and even innovators to register their products. And we will know if they will be applying for the nasal type or the oral type," he added.
Gutierrez said the FDA met with the Department of Health (DOH) for them to come out with a guideline on the use of home test kits "considering that these products need to be administered by the patient or the household themselves."
"So we need guidelines on the use, reporting system, even disposal of the waste, interpretation of the test results, and what actions should the individual take when he finds out that he is positive," he said.
"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 added. Robina Asido/DMS
