SunStar
Image from FDA January 18, 2021 THE Food and Drug Administration (FDA) has warned all healthcare professionals and the public not to purchase and use the unnotified medical device product AideLai Disposable Face Mask.
In an advisory, the FDA said it has verified through post-marketing surveillance that the AideLai Disposable Face Mask is not notified and no corresponding Product Notification Certificate has been issued.
Pursuant to Republic Act 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.
FDA warns public against purchase, use of unnotified AiDeLai face mask By JAMIL SANTOS, GMA News
Published January 15, 2021 1:58pm
Updated January 15, 2021 10:47pm The Food and Drug Administration has warned healthcare professionals and the public on the purchase and use of AiDeLai disposable face masks, which were found to be unnotified or without proper authorization. The FDA verified through post-marketing surveillance that the above mentioned medical device product is not notified and no corresponding Product Notification Certificate has been issued, the FDA said in its advisory. Citing Republic Act No. 9711 or the Food and Drug Administration (FDA) Act of 2009, the agency said that the manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product without the proper authorization is prohibited.