5-7-2020 Updates To The FDA Emergency Use Authorization EUA Appendix A
On May 7, 2020, the FDA revised their Emergency Use Authorization (EUA) for Non-NIOSH Approved Respirators During the COVID-19 Pandemic. Prior to this change, the Appendix A list had over 80 Chinese companies that were approved to have their respirators imported into the US. However, after testing was done by National Personal Protective Technology Laboratory (NPPTL), many samples did not meet the correct standards. All of these reports were publicly published by the CDC. Now, the Appendix A list has been reduced to only 14 companies. However, this is not to say that ALL of the companies that were removed from the list were of poor or unacceptable quality. The FDA has put stricter policies in place and companies are able to re-apply under these new guidelines.
Factories will now have to achieve one of the three criteria to be listed under the EUA:
- Holds one or more NIOSH approvals for other models of FFRs
- Hold a Chinese National Medical Products Administration (NMPA) registration certification by an appropriate provincial or municipal regulatory authority that is authenticated and verified by FDA. Several of our factories that were on the Appendix A list have already re-applied under this criteria.
- All of the following:
- Previously listed in Appendix A under the April 3, 2020 EUA because it demonstrated acceptable performance to applicable standards as documented by test reports
- Particulate filtration efficiency assessed by NIOSH using a modified version of NIOSH’s Standard Test Procedure (STP) TEBAPR-STP-0059 within 45 calendar days of the date of issuance of this EUA
- Results of NIOSH testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95%
Unfortunately, there are some previous Appendix A factories that did not pass the modified NIOSH testing. These are the factories that were explicitly mentioned by the FDA for not passing the 95% threshold.
- CTT Co. Ltd
- Dongguan Xianda Medical Equipment Co., Ltd.
- Daddybaby Co. Ltd
- Guangdong Fei Fan Mstar Technology LTD
- Guangdong Nuokang Medical Technology Co., Ltd.
- Huizhou Huinuo Technology Co., Ltd.
- Lanshan Shendun Technology Co.
Key Takeaway: In the previous months, PPE Trade and Support tested several EUA factories that failed our due diligence. Therefore, we already knew that the previous EUA list was not the best gauge of quality and efficacy. Ultimately, it comes down to testing the products directly and by an authorized testing lab that can be verified by the FDA. We only carry products that can meet this 3rd party testing standard.