Invisi Smart Draws FDA Warning Letter for Unapproved COVID-19 Masks
The FDA issued a warning letter to Invisi Smart Technologies UK for marketing unapproved masks that it claims protect against COVID-19.
The FDA cited the London-based company’s promotion of three models of its Invisi Smart Mask. The company has been making such claims as “Invisi Smart Mask kills viruses and bacteria as they come into contact with the mask allowing you to wear your mask with confidence all day… and for the next 30 days!”
The FDA said it contacted the company in October 2020 and informed it that it had to submit a premarket notification submission before marketing the devices in the U.S. But the agency reviewed the company’s websites on June 21 and found that the products were still being marketed without FDA approval, clearance or authorization.