FDA: Some respirators, other devices displaying misleading certificates

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FDA: Some respirators, other devices displaying misleading certificates
tjordan_drupal
Mar 3, 2021

The Food and Drug Administration has called on 25 firms to stop producing and issuing so-called “FDA registration certificates” to mask, respirator, face shield and other medical device makers and distributors that create the impression that FDA has approved or authorized their products.

FDA does not issue registration certificates to device makers that register or list their products with the agency.

Health care providers can check FDA’s emergency use authorizations and medical device databases for authorized or approved devices, and report suspected misuse of registration certificates.

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FDA: Some respirators, other devices displaying misleading certificates
tjordan_drupal
Mar 3, 2021

The Food and Drug Administration has called on 25 firms to stop producing and issuing so-called “FDA registration certificates” to mask, respirator, face shield and other medical device makers and distributors that create the impression that FDA has approved or authorized their products.

FDA does not issue registration certificates to device makers that register or list their products with the agency.

Health care providers can check FDA’s emergency use authorizations and medical device databases for authorized or approved devices, and report suspected misuse of registration certificates.

COVID-19: CDC, FDA and CMS Guidance

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