The Food and Drug Administration (FDA) of the Philippines, through its FDA Advisory No.2021-0236 posted in Facebook today (Wednesday), February 16, 2021, warns all healthcare professionals and the general public not to purchase and use the following unnotified medical device products:
- CIGILENA KN95 FOLDED PROTECTIVE MASK
- WISTECH UV MASK SURGICAL FACE MASK
According to the FDA, it has verified through post-marketing surveillance that the said medical device products are not notified and no corresponding Product Notification Certificates have been issued. Since the products have not gone through FDA’s evaluation process, the agency stated that it cannot assure the products’ quality and safety.
Moreover, the FDA also warned the concerned establishments not to distribute, advertise, or sell the violative products until the Product Notification Certificates are issued.
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