On April 3, 2020, the Food and Drug Administration (FDA) issued a new emergency use authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China. This EUA supplements the March 28, 20201 EUA for Non-NIOSH-Approved Imported FFRs, which authorized the emergency use of use of certain imported disposable FFRs that are not NIOSH-approved (we discussed this authorization in a previous client alert). Notably, the March 28 EUA does not authorize any respirators manufactured in China in part due to FDA’s concerns about fraudulent respirators. In the April 3 EUA, FDA lists respirator models from authorized Chinese manufacturers in Appendix A.
FDA also explains that at least one of the following criteria must be met for non-NIOSH approved respirators manufactured in China to be eligible for Appendix A:
- Manufactured by an entity that holds one or more NIOSH approvals for other models of FFRs produced in accordance with the applicable standards of authorization in other countries that can be verified by FDA.
- Regulatory authorization under a jurisdiction other than China that can be authenticated and verified by FDA.
- Demonstrates acceptable performance to applicable testing standards as documented by test reports from a recognized independent test laboratory that can be verified by FDA.
Once FDA confirms a respirator meets one of the criteria, FDA will identify the product on Appendix A as authorized for use under the EUA. Authorized respirators used in accordance with the EUA are not subject to Good Manufacturing Practice requirements, including the Quality System regulation requirements for the design, manufacture, packaging, labeling, storage and distribution of the respirators.
Manufacturers and importers of authorized respirators have additional responsibilities and restrictions, including that they:
- Do not claim or suggest the authorized respirator is safe or effective for the prevention of COVID-19.
- Ensure descriptive printed materials relating to the use of the authorized respirators are consistent with CDC recommendations and the EUA.
- Publish the intended use and other instructions for authorized models on their website in English.
- Provide a letter to each end user facility with key product details.
Refer to the full text of the EUA for a complete description of responsibilities.
Although FDA has established a process for authorizing and importing Chinese-manufactured respirators, China has tightened requirements for the export of Chinese medical supplies in an effort to improve quality. On March 31, 2020, the Chinese Ministry of Commerce announced that all “exportable medical supplies must obtain relevant qualifications and meet the quality standards of the importing country or region.” A Chinese exporter of coronavirus test kits, medical use face masks/respirators and personal protective equipment (PPE), ventilators, and infrared external thermometers will need to meet two requirements. First, the product/device must be registered in China and have a PRC Medical Device Product Registration Certificate. Second, the product/device must comply with the quality standards of the importing country; and, the Chinese exporter will need to attest that the imported products meet those requirements by signing a declaration form.
Revised Enforcement Policy for Face Masks and Respirators
FDA also revised the Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, which supersedes the enforcement policy issued on March 25, 2020. Most notable is the addition of Section V.F, which effectively allows the importation of KN95 respirators from China. In the enforcement policy, FDA says for the duration of the COVID-19 emergency it does not intend to object to the distribution and importation of respirators recommended by the CDC to use when FDA-cleared or NIOSH approved N95 respirators are unavailable. FDA will not object even if those respirators identified by CDC are not in compliance with 510(k) premarket notification, registration and listing requirements (21 CFR 807), quality system regulations (21 CFR 820), reports of corrections and removals (21 CFR Part 806), and Unique Device Identification requirements (21 CFR 801.20, 830). FDA recommends that importers implement appropriate steps to verify the authenticity of all respirators, because FDA cannot confirm their authenticity. Importers bringing respirators into the country that are not FDA cleared, NIOSH-approved, or pursuant to an EUA, will be doing so at their own risk.
FDA also added a section to the revised enforcement policy regarding face shields intended for a medical purpose and revised the section regarding surgical masks. Notably, FDA does not intend to object to distribution or use of these products even though these are not in compliance with 510(k) premarket notification, registration and listing requirements (21 CFR 807), quality system regulations (21 CFR 820), reports of corrections and removals (21 CFR Part 806), and Unique Device Identification requirements (21 CFR 801.20, 830). FDA believes such face shields and surgical masks will not create an undue risk if certain criteria identified in the Policy are met.
1 FDA issued the EUA on March 24, 2020, and then reissued the EUA in its entirety with minor amendments on March 28, 2020.
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