In the spirit of full transparency, Fusion Healthcare Solutions would like to make you aware of a recent change in the status of N95 and KN95 masks, pursuant to the updated guidance/memo released on May 7th by the FDA regarding approved manufacturers. Since the FDA issued the April 3, 2020 Emergency Use Authorization (EUA), new information has come to light that questions the performance of some of the respirators authorized under the EUA and included in Appendix A. For instance, the FDA has received testing data from the Centers for Disease Control and Prevention (CDC) and the National Institute for Occupational Safety and Health (NIOSH), who found that some of the respirators manufactured in China and listed did not meet the expected performance criteria of greater than or equal to 95 percent particulate efficiency. Based on this and other information provided by the CDC, the FDA has determined that in order to protect the health and safety it was appropriate to revise the April 3, it was appropriate to revise the April 3, 2020 EUA by making the following key changes:
- Revising the eligibility criterion allowing authorization based on acceptable performance to standards documented by independent laboratory testing.
- Removing the ability of importers to apply for the EUA and directing manufacturers to provide a list of authorized importers, and;
- Adding recognition of the Chinese National Medical Products Association (NMPA) registration certification that can be verified by the FDA.
Prior to May 7th our masks met all criteria by the guidance set forth, additionally our masks were not manufactured by any of the 8 factories that completely failed to demonstrate particulate filtration efficiency of 95% in testing conducted by NIOSH. On March 24, 2020, in response to this evolving public health emergency and continued filtering facepiece respirator (FFR or respirator) shortages, the FDA concluded based on the totality of scientific evidence available that certain imported disposable FFRs that are not NIOSH approved are appropriate to protect the public health or safety (as described under section II Scope of Authorization) under section 564 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360bbb-3).
Currently, we are in the process of ascertaining from our manufacture’s, if they will be submitting all the necessary documentation for their respirator(s) to be added to the aforementioned, Appendix A, if they meet the following eligibility criterion; one (i.e., you hold one or more NIOSH approvals for other models of respirators) or criterion two (i.e., the model for which you are requesting emergency use authorization has a regulatory authorization under a jurisdiction that can be authenticated and verified by the FDA). The request will continue to be reviewed to determine criteria.
In summary, we will continue to follow all FDA and CDC respirator guidance, specifically, we will only be supplying NIOSH certified N95 masks, and approved KN95s until further guidance is released. Note: all sales on ‘date of purchase’ will be final and will not be subject for refund, regardless of future FDA/CDC manufacturer guidance and changes.
In light of the information above, we felt it was prudent for our business relationship that we disclose and memorialize this information and share our next steps, as we navigate and adapt to these ongoing changes as issued forth by all regulatory agencies. Hence, please, sign to acknowledgement your understanding of our position and next steps.
Please, contact us if you have any concerns.
Fusion Healthcare Solutions