FDA Warns Public Not to Use the Following Unnotified Face Masks

The Food and Drugs Administration (FDA) – Philippines has released advisories warning the public not to purchase and use the following disposable face masks:

FDA Advisory No.0011 and No.0010

As stated in separate advisories, the FDA is warning  all healthcare professionals and the general public not to purchase and use the unnotified medical device products:

According to the FDA advisories, the abovementioned products are not notified and no corresponding Product Notification Certificate has been issued. This was verified by FDA through post-marketing surveillance.

As stated under the FDA Act of 2009, without the proper authorization, the following is prohibited:

• manufacture
• importation
• exportation
• sale
• offering for sale
• distribution
• transfer
• non-consumer use
• promotion
• advertising or sponsorship of health products

Furthermore, FDA has stated that since the unnotified medical device product has not gone through the evaluation process of  FDA, the agency cannot assure the product’s quality and safety.

“All concerned establishments are warned not to distribute, advertise, or sell the said violative medical device product until the product notification issued, otherwise, regulatory actions and sanctions shall be pursued,” FDA added.

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Source: FDA Advisory No.0011 and No.0010