The Food and Drug Administration (FDA) has approved two (2) self-administered COVID-19 antigen test kits in compliance with the application requirements listed in the FDA Advisory No. 2021-0684 entitled “Guidance on the Process for the Issuance of Special Certification for COVID-19 Test Kits Based on FDA Memorandum No. 2020-006 and FDA Memorandum No. 2021-009.” These kits can be used by individuals to detect SARS-CoV-2 antigen from nasal swab of probable COVID-19 patients. Guidelines for the use of these kits shall be released by the Department of Health.
The FDA has updated the list of approved COVID-19 test kits, to include the self administered test kits with Special Certification and is available at the FDA website. This list will be regularly updated.
The FDA remains steadfast in ensuring that all related COVID-19 applications are processed
upon receipt of the result of performance validation from RITM.
We ask the public and stakeholders to be vigilant in the purchase of these COVID-19 test kits. To ensure safety, efficacy and quality of these health products, you are advised to source your COVID-19 test kits from FDA authorized importers who are holders of the Certification for the COVID-19 test kits or their duly authorized FDA licensed distributors.