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.