Due to the impact of the epidemic, for the EUA of KN95 masks in China, the FDA is requested to quickly review the mask data in a short period of time, and publish the enterprises and product models authorized by the EUA on the official website, which is equivalent to issuing a temporary simple certificate to replace NIOSH certification.

The difference between EUA and NIOHS certification is:

On April 3, the US FDA issued a document on its official website specifically for the EUA authorization of the masks produced in China that are not NIOSH certified.

The US FDA has excluded Chinese standard KN95 masks from the scope of EUA authorization, and this newly released document marks the official recognition of KN95 masks produced in accordance with Chinese standards.

Put simply. NIOSH certification does not need to be processed, changed to EUA certification

EUA certification is valid only for the duration of the outbreak, NIOSH certification is valid for a long time

EUA certification does not require factory inspection NIOSH certification requires factory inspection

Handling the EUA is equivalent to being closely regulated by the FDA, and companies must commit to meet the following conditions in order to accept FDA investigations at any time.

A. The manufacturer must provide the use, method of use, and other instructions (such as suitability tests, etc.) of the model authorized by the EUA.

B. The manufacturer should provide a letter in English for distribution to various end users (such as hospitals), which must include the authorized mask manufacturer, model, intended use, manufacturer's web page, etc.

C. The manufacturer must inform the importer of the terms and conditions of this EUA and ensure that end-user facilities receiving authorized masks (e.g. hospitals, etc.) receive the information required under Condition B.

D. The authorized manufacturer shall establish a procedure for reporting adverse events and send these reports to FDA.

E. All descriptive printed materials should be consistent with applicable CDC recommendations used during the COVID-19 outbreak and with the terminology specified in this EUA. (That is to say, the protection capability that is not consistent with the substance of the product cannot be advertised)

F. Any descriptive printed material relating to the use of authorized face masks in the United States must not express or imply that the product is safe or effective for the prevention of COVID-19.

G. Manufacturers of authorized masks will ensure that any records relating to this EUA are maintained until further notice by FDA. Upon request, these records will be made available to FDA for inspection.

At present, there are at least 10 million masks registered with the FDA, and only 8 Chinese enterprises authorized by the EUA, including 3M Taiwan enterprises, may have customers who need to apply for EUA approval in the future.

The scope of the EUA application is for disposable protective masks manufactured in China, with a vertical shape. Medical flat masks are not included.

What are the requirements for application:

Chinese-made protective masks without any NIOSH certification can apply to the FDA for emergency approval (EUA) if they meet one of the following three conditions.

1. Other models produced by the factory have passed NIOSH official certification (such as N95 certification)

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3. Meet the market injection of other countries and FDA validation

4. Qualified third-party testing reports can prove that the product meets the relevant standards and can provide proof for FDA validation (products designed and verified according to the relevant standards in China).

Tip: Of the three options, the third condition is relatively easy to meet.

Reminder: EUA approval is only an emergency plan, and NIOSH certification will need to be re-done after the outbreak is over