EUA for non-NIOSH approved 95N respirators
On 24 March 2020, FDA issued an EUA for the use of N95 disposable filtering face-piece respirators (FFRs) that are non-NIOSH-approved. The Letter of Authorization states that FDA has concluded that certain imported disposable FFRs that are not NIOSH-approved may still be appropriate to protect the public health or safety if they are used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during the shortages of FFRs as a result of the COVID-19 outbreak. The Letter of Authorization provides specific details regarding which respirators are authorized under this EUA. To be eligible, the respirator must: (i) meet the applicable standards in place in Australia, Brazil, Europe, Japan, Korea, or Mexico; and/or (ii) be authorized for marketing in Europe, Australia, Canada, or Japan. If a manufacturer or importer believes that its respirators are within the scope of this EUA, they must notify FDA by email of their intent to import non-NIOSH approved disposable respirators that are eligible under this EUA before importing into the United States. Additional labeling requirements and other restrictions apply, as outlined in the guidance.
However, as part of the EUA, certain standard FDA regulatory requirements are waived, including compliance with the quality system requirements (QSR) under 21 CFR Part 820 with respect to the design, manufacture, packaging, labeling, storage, and distribution. For additional information, FDA also published Non-NIOSH Approved Respirator Emergency Use Authorization (EUA) Frequently Asked Questions (FAQ). In addition, on 23 March 2020, U.S. Customs and Border Protection issued a bulletin that indicated that reduced information was required for importing personal protection equipment and certain other medical devices during the COVID-19 outbreak. Customs is not requiring facility registration and device listing information as required under 21 CFR Part 807 for these devices. Importers should include a specified product code and a statement that the product fits within FDA’s guidance on the shipping documents.
Surgical masks with fluid resistance data
Based on our communications with FDA, the agency has indicated that during the COVID-19 Public Health Emergency it will not object to the marketing and distribution of surgical masks in the health care setting without prior 510(k) clearance if the product meets the following recommendations:
- Meets fluid resistance testing (liquid barrier performance) consistent with standard ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity).
- Meets Class I or Class II flammability requirement per 16 CFR 1610 (unless labeled with a recommendation against use in the presence of high intensity heat source or flammable gas); and
- The labeling is consistent with the following:
- Described as a “surgical mask”;
- Does not include uses for antimicrobial or antiviral, protection or related uses;
- Does not include uses for infection prevention or reduction or related uses;
- Does not make particulate filtration claims; and
- Contains a list of the body contacting materials, which should not include any drugs or biologics.
Non-surgical masks without fluid resistance data (face masks)
FDA has also indicated that it will not object to the marketing and distribution of face masks in the health care setting without prior 510(k) during the COVID-19 Public Health Emergency if the product is labeled in the following manner:
- It states it may be used when FDA cleared masks are unavailable;
- It recommends against use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected;
- It makes no claims of antimicrobial or antiviral protection;
- It makes no claims of infection prevention or reduction;
- It makes no claims regarding flammability;
- The labeling contains a list of the body contacting materials;
- The mask is not labeled as a "surgical mask”; rather it may be labeled as a “face mask.”
Importantly, FDA has also communicated that it does not intend to object to the marketing of face masks that meet the criteria listed if they that are manufactured in a facility that does not meet the QSR requirements of 21 CFR Part 820. We expect an official statement from FDA regarding this policy within the next day.
Impact on industry going forward
These new EUA policies significantly reduce the burdens for the entry of new respirators and masks to the medical community in the U.S. Companies should closely follow the requirements outlined in the policy for respirators and consult the associated FAQ document with regard to FDA notifications, labeling requirements, and follow-up with the agency. Similar guidance, exemptions, and restrictions are likely to be implemented for masks as well. It should be noted that each of the EUAs and enforcement discretion policies only apply until the circumstances created by the COVID-19 outbreak no longer exist. Should companies wish to continue marketing these products after the emergency circumstances have subsided, the standard FDA regulatory requirements would apply.
We will continue to monitor FDA’s response to COVID-19. Please contact us if you have any questions.
Authored by Michael Heyl, Lina Kontos, Seth Olson