The Food and Drug Administration (FDA) warns all healthcare professionals and the general public against the purchase and use of the Uncertified COVID-19 Test Kit “Femometer Covid-19 IgG/IgM Rapid Test Cassette“.
The FDA verified through post-marketing surveillance that the abovementioned medical device is not certified and/or no FDA Special Certification has been issued as of 15 May 2020.Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of health products without the proper authorization is prohibited.
Since these uncertified medical devices have not gone through evaluation process of the FDA, the agency cannot assure its quality and safety.
Furthermore, FDA Circular No. 2016-016 entitled “Prohibition of Online Selling of FDA Certified Covid-19 Antibody Test Kits “prohibits online selling and commercial use of such products.
For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health and Research through e-mail at [email protected], or call (02) 8857-1900 loc. 8301.
To report any sale or distribution of unregistered/uncertified medical device, email us at [email protected].
Dissemination of this advisory to all concerned is hereby requested.
Attachment:-> FDA Advisory No.2020-1012