Starting from April 3 2020, the quick answer is “YES” but with certain conditions.
The US FDA has just officially announced that it will allow China-made KN95 to be used in the US during the COVID-19 pandemic outbreak in healthcare settings. Essentially, non-NIOSH-approved respirators that have obtained China’s KN95 certification are eligible to apply for a new FDA authorization before they can be imported to the US and used by healthcare personnel (HCP) in the US, provided certain quality criteria are met.
IS MY KN95 QUALIFIED FOR THIS AUTHORIZATION?
Your KN95 is now eligible to apply for this authorization for the US market, if you can demonstrate to the FDA some additional quality proof of your respirator, in addition to your KN95 certification:
- The same manufacturer of your KN95 has US NIOSH-approvals for FFR models;
- Your KN95 has obtained a NIOSH N95-equivalent certification outside China that FDA recognizes; Or
- Your KN95 comes with a test report issued by an FDA-recognized independent test lab.
In essence, FDA is saying that beyond your KN95 certification issued by China, you need to provide another quality proof that your KN95 really meets US NIOSH N95 or standard or another one that is N95 equivalent.
HOW TO APPLY FOR THIS AUTHORIZATION?
Here is the workflow for KN95 manufacturers to obtain needed FDA authorization before importing their products to the US, during the period of the COVID-19 outbreak:
This KN95 US authorization contains two phases
- PRE-MARKET: Choose one of the three proof criteria path established by the FDA. Prepare and collect all needed documents, certifications, quality proof. Create an FDA application and submit all required information. Respond, follow up and interact with FDA in English during the application process towards obtaining a timely authorization.
- POST-MARKET: KN95 manufacturers must meet all post-market requirements in order to market their products in the US, including but not limited to
- Publish and maintain an English website for your KN95 and other products marketable in the US, using FDA-approved verbiage for the intended use, fit testing, and other product information and instructions.
- Produce and distribute a letter in English for US end-user facilities containing FDA-required information.
- Establish and manage a process for reporting adverse events in the US of which they become aware and send regulated reports to the US FDA. You must keep the the communications channel open with FDA.
- Only use regulated language for your KN95 with no false advertising. All descriptive material relating to the product itself and the use of it in the US must be consistent with applicable CDC recommendations during
the COVID-19 outbreak. None of them may represent or suggest that the product is safe or effective for the prevention of COVID-19.
It is important to take notice that FDA will remove our your KN95 US authorization, if any of the post-market requirements are not met, or if you lost communications with FDA.
HOW SOON CAN I IMPORT MY KN95 TO US?
During the COVID-19 pandemic, once FDA authorizes your KN95, you can immediately import and distribute your product to US healthcare personnel (HCP) in healthcare settings.
WHY WORK WITH GREENPPE?
Located in the US and working as their extended team, our FDA experts are helping overseas KN95 manufacturers and suppliers review, submit, follow up and interact with FDA for a timely US authorization during the COVID-19 outbreak. In addition, GreenPPE provides all-inclusive support that covers FDA-mandated post-market items for the US market, including but not limited to: creating and managing a product English website, creating and distributing the US end-user letter, reviewing product label and other product information in English against FDA and CDC standards, and checking and removal of false advertising.
Once your KN95 is authorized by the FDA, GreePPE can also directly link you with volume buyers from both public and private sectors US. We do this to help fight the COVID-19 outbreak.
We’d like to do our part by sending you a free estimate about the qualification of your KN95 for this FDA authorization for the US market. This is now the only road block between your KN95s and the US market.