BULGAR
Jan 15, 2021
ni Ronalyn Seminiano Reonico | January 15, 2021
Nagbabala ang Food and Drug Administration (FDA) sa mga healthcare professionals at sa publiko sa paggamit at pagbili ng 2 brands ng “unnotified” disposable face masks.
Ayon kay FDA Director-General Eric Domingo, ang “Disposable Medical Mask” at “AiDeLai Disposable Face Mask” ay kapwa “unnotified medical devices products.”
Aniya pa, hindi nabigyan ng Product Notification Certificates ang mga naturang brands.
Pahayag ng FDA, "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.”
Paalala rin ng naturang ahensiya, “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 proper authorization is prohibited.”
Hindi rin umano nakasisiguro ang FDA sa quality at safety ng naturang brands dahil hindi dumaan ang mga ito sa evaluation process ng ahensiya.
Samantala, nakikipag-ugnayan na rin ang FDA sa awtoridad at local government units upang masigurong hindi maibebenta sa merkado ang mga naturang brands ng face masks.