The Food and Drug Administration (FDA) informs all concerned stakeholders and the general public that to date, there is no FDA Certified COVID-19 Test Kits for Self-Administration.
In light of the foregoing, all healthcare professionals and the general public are advised not to purchase and use these in-vitro devices.
All concerned establishments are warned not to distribute, advertise, or sell the said Uncertified medical device until FDA Special Certification is issued, otherwise, regulatory actions and sanctions shall be strictly pursued.
All FDA Regional Field Offices and Regulatory Enforcement Units in coordination with law enforcement agencies and Local Government Units are requested to ensure that this product is not sold or made available in the market or their areas of jurisdiction.
The Bureau of Customs is urged to restrain the entry of this uncertified product.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at cdrrhr@fda.gov.ph, or call (02) 8857-1900 loc. 8301.
To report any sale or distribution of unauthorized medical device, the online reporting facility, eReport can be accessed at www.fda.gov.ph/ereport.
Self-administered COVID-19 test kit
In November 2020, the FDA in the United States approved the first COVID-19 test kit for self-testing at home.
The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop-mediated amplification reaction) single-use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.
“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D.
“Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
“The test works by swirling the self-collected sample swab in a vial that is then placed in the test unit. In 30 minutes or less, the results can be read directly from the test unit’s light-up display that shows whether a person is positive or negative for the SARS-CoV-2 virus. Positive results indicate the presence of SARS-CoV-2,” FDA USA said.