In the interest of service, the Food and Drug Administration (FDA) warns all healthcare professionals and the general public NOT TO PURCHASE AND USE the Covid-19 Test Kits from Unauthorized Importer/Distributor and to further reiterate that online selling of COVID-19 test kits are strictly prohibited.
Moreover, the FDA hereby informs all concerned stakeholders and the general public that, as of this date, there are no FDA certified self-administer COVID-19 test kits.
In view of the above, the FDA highly encourages to acquire FDA certified COVID-19 test kits through authorized importers or their authorized distributors with LTO.
All FDA Regional Field Offices and Regulatory Enforcement Units are directed to conduct exhaustive monitoring of improper distribution and dispensing of all COVID-19 test kits including online platforms to ensure full compliance of this Advisory and to pursue and implement immediate regulatory and enforcement actions as warranted.
For more information and inquiries about this advisory, kindly contact the FDA CDRRHR through e-mail at [email protected] indicating on the subject the concerned Advisory, or call (02) 8857-1900 loc. 8301.
To report any sale or distribution of uncertified medical device, contact the online reporting facility eReport through e-mail at [email protected].
Dissemination of this advisory to all concerned is hereby requested.