FDA warns vs selling of unauthorized COVID-19 test kits

March 13, 2020

Amid the growing threat of the coronavirus disease 2019 (COVID-19), the Food and Drug Administration (FDA) Friday warned the public against selling unauthorized testing kits. 

Based on FDA Circular No. 2020-004, all healthcare professionals, stakeholders, and the general public are being advised not to distribute, sell, or use COVID-­19 testing kits without FDA authorization. 

"All concerned establishments are warned not to distribute, advertise, or sell COVID-19 testing kit until a corresponding authorization has been issued by FDA; Otherwise, regulatory actions and sanctions shall be strictly pursued," said the FDA. 

This is to ensure only COVID-19 testing kits that have passed government quality standards will be used in the country. 

The health agency said all FDA regional field offices and regulatory enforcement units, in coordination with law enforcement agencies and local government units, are urged to ensure that only COVID-­19 testing kit with FDA authorization is sold or made available in the market.

The FDA is urging the Bureau of Customs to restrain the entry of COVID-19 testing kit without FDA authorization.

In a related development, the FDA said it will be issuing Certificate of Exemption to imported COVID-19 test kits if they meet regulatory standards. 

Based on FDA Circular No. 2020-006, the agency acknowledged the need for more quality test kits as the COVID-19 spreads in the country. 

"With the expanding global outbreak of a respiratory illness caused by COVID-19, the Center for Device Regulation, Radiation Health and Research shall be issuing a special certification for imported in-vitro diagnostic (IVD) kits used for diagnosis and screening of COVID-19," said the FDA. 

Earlier in the week, the FDA granted a Certificate of Exemption for the SARS CoV-2 PCR Detection Kit of the University of the Philippines - National Institute of Health (UP­-NIH). DMS