Effective May 7, 2020, the FDA banned 65 respirator (N95-type masks) manufacturers in China from its approved list of manufacturers. Only 14 manufacturers remain. Suppliers of respirators, such as N95 masks for use in hospitals and Emergency Use Authorization (EAU), should be aware of the updated “Appendix A” which you can find here.
The new list was adjusted to address significant shortfalls in the safety and health standards used by other manufacturers previously included on the approved list due to emergent need. The FDA has now taken the time to test the adequacy of all such products. As a result, the new list of the 14 approved manufacturers will increase quality of masks used by healthcare workers and other businesses in the United States as only FDA approved masks will be formally certified in connection with the customs process.
Who might this impact?
These changes will impact hospitals, large health systems, and other businesses using NIOSH or 3M FDA approved masks. Many of them will have to immediately shift their purchasing standards and find new resources. These changes are likely to have an impact on every part of the supply chain - purchasers, suppliers, warehouses, sales representatives, resellers, logistics companies, customs brokers etc.
What issues might impacted parties need to consider?
- Parties may be liable for selling or using inventory from manufacturers no longer on the approved list.
- Buyers may be bound by executed purchase orders of products from banned manufacturers, but this may hinge on the terms and conditions of delivery and title and the effective date of the FDA certification.
- Businesses may be impacted by their ability to operate at the same capacity level due to a decrease in the supply of PPE.
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