Due to the impact of the epidemic, for the EUA application of Chinese KN95 masks, FDA will quickly review the mask information in a short period of time, and publish the EUA authorized companies and product models on the official website, which is equivalent to issuing a temporary summary certificate to replace NIOSH certification. Recently, a large number of customers consulted the EUA and raised questions. ZRLK organized the problems and answered them one by one.
Faqs for EUA certification
01. What is EUA certification?
Answer: The US Food and Drug Administration (FDA-Food and Drug Administration) during the outbreak of the new coronavirus (COVID-19) for medical products and civil protection products did not obtain NIOSH certification for emergency use authorization of Chinese companies (Emergency Use Authorization (EUA)) open white list, assistant enterprises export medical protection materials for epidemic situation to the United States.
02. What is the difference between EUA certification and NIOHS certification?
Answer: On April 3rd, the US FDA issued a document on its official website specifically for obtaining EUA authorization for non-NIOSH certified (masks) produced in China. The US FDA once excluded the Chinese standard KN95 mask from the scope of the EUA authorization. This newly released document marks that the KN95 mask produced in accordance with Chinese standards has been officially approved by the United States. Simply put, NIOSH certification does not need to be processed, and it is changed to EUA certification.
EUA certification is only valid during the outbreak, and NIOSH certification is valid for a long time.
EUA certification does not require factory inspection, and NIOSH certification requires factory inspection to handle EUA, which is equivalent to strict supervision by the FDA. Enterprises must promise to meet the following conditions in order to accept FDA investigations at any time.
A. The manufacturer must provide the use, usage, and other instructions of the EUA authorized model (such as suitability testing, etc.).
B. The manufacturer must provide an English letter to be distributed to various end users (such as hospitals). This letter must include the manufacturer, model, intended use, and manufacturer's website of the authorized mask.
C. The manufacturer must notify the importer of these EUA terms and conditions and ensure that the end-user facility (such as hospitals, etc.) receiving the authorized mask receives the information required by Condition B.
D. Authorized manufacturers shall establish a procedure for reporting adverse events and send these reports to FDA.
E. All descriptive printed materials should be consistent with the applicable CDC recommendations used during the COVID-19 outbreak and the terms specified in this EUA. (In other words, it is not possible to promote protection capabilities that do not conform to the actual situation of this product)
F. Any descriptive printed matter related to the use of authorized masks in the United States shall not express or imply that the product is safe or effective in preventing COVID-19.
G. The manufacturer of authorized masks will ensure that any records related to this EUA are kept until further notice by FDA. Upon request, these records will be provided to FDA for inspection.
The scope of EUA application is a disposable protective mask produced in China, three-dimensional type. Medical plane masks are out of range.
03. What are the requirements for applying for EUA certification?
Answer: China-made protective masks without any NIOSH certification can apply to the FDA for emergency approval (EUA) as long as they meet one of the following three conditions.
1. Other models produced by the factory have passed NIOSH official certification (for example, obtained N95 certification)
2. To meet the market injection of other countries and FDA verification of the living room
3. A qualified third-party test report can prove that the product meets the relevant standards, and can provide certification to the FDA for verification (products designed and verified according to relevant Chinese standards).
Tips: Among the three options, the third condition is relatively easy to meet.
Reminder: EUA approval is only an emergency plan, and NIOSH certification needs to be done again after the outbreak
04. How to do EUA certification? What the process is like?
Answer: Provide a copy of GB2626 English quality inspection report or CE report + data technical document questionnaire covered by CNAS and CMA, and complete EUA in 1-2 weeks (submit product authorization application, upload information, FDA review, rectification, FDA final decision) . No matter how the emergency measures in Europe and America are changed, on the basis of product compliance, it is necessary to complete product related testing and prepare relevant technical documents.
05. Do samples need to be sent to the US for testing? Do you need a US agent?
Answer: No, just provide a valid 2626 or CE report. No U.S. agent is required at the time of registration, and a valid report + data technical document is provided to complete the EUA registration approval.
06. Has ZRLK ever been included? Is there a certificate?
A: No pass, but ZRLK promises a full refund for unsuccessful registration. EUA does not have a certificate. After completion, we will give a formal confirmation letter to inform the registered information and inquiry link.
07. How long is the EUA authorization valid?
A: The new coronavirus (COVID-19) is valid during the epidemic. After the end, you need to apply for NIOSH certification. The specific time should pay attention to the latest FDA information, and you can always ask the ZRLK engineer.
08. What products are included in the EUA authorization?
Answer: Many, KN95 masks, face masks, air purification systems, battery sterilization systems, medical equipment, etc. made in China. We make EUAs for face masks and face masks.
In Vitro Diagnostic Products, High Complexity
Molecular-Based Laboratory Developed Tests, Personal
Protective Equipment and Decontamination Systems, Ventilators
and Other Medical Devices, Therapeutics
In vitro diagnostic products, tests developed by highly complex molecular basic laboratories, personal protective equipment and purification systems, ventilators and other medical equipment, therapeutic drugs
09. Is the EUA fake?
Answer: Not fake! On April 3, 2020, the US Food and Drug Administration issued a letter: Imported disposable filter respirator manufacturers or emergency use authorizations not approved by NIOSH; masks from authorized companies can enter the United States. The scope of use includes: hygiene Health personnel; hospital procurement departments and distributors; importers and commercial wholesalers; and any other applicable stakeholders.
