In March 2020, the US Secretary of Health declared that circumstances exist justifying the authorization of emergency use of certain personal protective equipment (PPE) during the COVID-19 outbreak, subject to the terms of any authorization issued under that section.

The Emergency Use Authorization allows FDA to help strengthen the nation’s public health protections against certain threats by facilitating the availability and use of resources needed during public health emergencies. As the result, FDA has established an expedited approval process for certain PPE products for overseas manufacturers and suppliers.  

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Compared to the months of time with the regular FDA PPE approval process, now we can send your PPE products through the expedited approval process, specially established by the FDA during the US COVID-19 outbreak time. Each case is different but we have helped overseas PPE manufacturers and suppliers obtain the FDA approval for US entry within a week.

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With the new FDA PPE COVID-19 process, your N95-equivalent respirator product produced outside of the US does not need to be N95 certified by the NIOSH. Instead, you can applying now for an FDA emergency authorization to enter the US market, provided your product meets N95-equivalent product standard in Australia, Brazil, EU, Japan, Korea, or Mexico. 

For China-made KN95 respirators, you should apply for the same FDA authorization if your product already has the CE marking for the EU market. Check here for more information

To take advantage of FDA’s expedited approval process during the COVID-19 outbreak, you should check whether

  • Your product meets certain non-US standards such as EU’s (CE Marked) that FDA deems equivalent to its own standards
  • You have English product labeling that meets FDA requirements.
  • You have a English website and posted FDA-required product information
  • You have prepared a product information letter to US end-user facilities
  • You have a contact in place for product support and FDA inquiries

Doesn’t have all of them or not sure? Don’t worry – GreenPPE team is ready to help. Our US-based FDA experts are getting the much-needed FDA authorization and required post-market support for overseas PPE manufacturers and suppliers. Each case is different – you could get the FDA authorization pretty quickly within several days.  

Fill this simple form and let us send you within 24 hours a free confidential US market readiness report for your PPE product. 


Posted in FAQ