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The Food and Drug Administration (FDA) warns the public against unapproved and misleading advertisements and promotion of various medical devices monitored as part of the post market surveillance activity of the Regional Field Office.

  1. BioMask™ Flat+™  Medical Face Mask
  2. RespoKare® Active Protection Mask Anti-Viral Mask

The public is hereby advised to be vigilant against such deceptive marketing of medical devices. Ear loop facemask shall not, in any way, cure and specially kill viruses and bacteria like influenza A and SARS and any other diseases, and should not bear any misleading, deceptive and false claims on their labels and/or any promotional materials that will provide erroneous impression on the product’s character or identity.

Further, the FDA would like to emphasize that of this time, there are no specific treatments for COVID-19. Everyone is encouraged to follow accurate public health advice and guidance from the Department of Health and the World Health Organization on basic protective measures against COVID -19.

All Marketing Authorization Holders of these medical devices are sternly warned and hereby
directed to stop such misleading advertisements and promotions. Appropriate regulatory tools and sanctions shall be executed to such companies that are continuously conducting such and similar activities upon issuance of this Advisory.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA Advisory No.2020-782