The Food and Drug Administration (FDA) has warned the public against the selling of unauthorized coronavirus disease 2019 (COVID-19) test kits.
The agency advised all healthcare professionals, stakeholders, and the general public not to distribute, sell, or use COVID-¬19 testing kits without authorization from the FDA.
“This is to ensure the provision of accurate and reliable information regarding result of the COVID-19 test to be conducted,” the FDA said in its advisory no. 2020-004.
“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,” it added.
The FDA also urged the Bureau of Customs to restrain the entry of COVID-19 testing kits without the agency’s authorization.
“All FDA regional field offices and regulatory enforcement units in coordination with law enforcement agencies and local government units are requested to ensure that only COVID-19 testing kit with FDA authorization is sold or made available in the market or their areas of jurisdiction,” it added.
To note, the FDA recently issued a “certificate of exemption” for the SARS CoV-2 PCR Detection Kit developed by the University of the Philippines – National Institute of Health (UP-NIH).
FDA Director-General Rolando Enrique Domingo said that the locally-developed test kit will help in addressing “the increasing number of reported COVID 19 cases [that] will require immediate diagnosis and monitoring.” (Analou de Vera)
