FDA Warns Public Not to Purchase and Use Unnotified Face Masks
In two different Food and Drug Administration (FDA) Advisories, the agency has warned the public not to purchases and use unnotified medical device products or products that have not gone through the evaluation process of FDA.
Unnotified Medical Device Products
According to FDA Advisory No. 2020-2040, one of the unnotified medical device products healthcare professionals and the general public must not purchase and use is the FFP2 Protective Mask GB2626-2006 (Civil Grade) 5 Layers KN95.
Photo Source: FDA
Furthermore, in FDA Advisory No. 2020-2038, the public is warned not to purchase and use the following unnotified medical device products:
- Day Maker Disposable Face Mask
- AINBEI Disposable Protective Mask
Photo Source: FDA
In addition, according to FDA, the agency has verified through post-marketing surveillance that the above-mentioned medical products are not notified and no corresponding Product Notification Certificates have been issued. Pursuant to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, the manufacturer, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of health products without proper authorization is prohibited.
Source: FDA Advisory No. 2020-2038, FDA Advisory No. 2020-2040
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