FDA Expands EUA to Include more Imported Disposable Face Masks

Update 06/10/2020

On June 6, 2020, the FDA made several changes to EUAs for certain N95 respirators and Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. FDA issued EUAs for products used to decontaminate certain N95 respirators for multiple-user reuse by HCP.  Based on testing conducted by the CDC NIOSH on respirators made in China, FDA has now determined that, generally, authorized respirators made in China would not be authorized after decontamination. 

Update 05/07/2020

FDA issued a revised Emergency Use Authorization (EUA) for “disposable filtering facepiece respirators (FFR) manufactured in China that do not meet NIOSH standards.” This comes as a result of questions about the ability of the respirators to meet a minimum particulate filtration efficiency of 95% when testing by NIOSH. 

Note: This blog was updated 04/13/2020 to reflect new FDA guidance.

On March 24, 2020, FDA issued guidance extending an Emergency Use Authorization (EUA) to “Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFR) that have been validated to meet specific performance standards or have a marketing authorization in certain countries.” In an April 3, 2020 memo, FDA expanded the EUA to establish a pathway for certain non-NIOSH-approved masks manufactured in China (e.g., “KN95” masks.

As Ben England explains, “The upshot is that non-medical industrial respirators that ordinarily could not be used for medical purposes MAY NOW be used for medical purposes and they can be imported.” FDA does not seem to require registration and listing of the devices, which may change. However, FDA wants the manufacturer to post information on their websites in English (like donning instructions, indications for use, etc.), make sure the labeling complies with CDC requirements, create letters to hospitals and clinics with instructions and disclaimers…etc.

Below is a practical summary of the March 28 letter, and brief explanations on how to proceed.  This is good news for everyone, but there are important and detailed steps to follow. Please contact us, so we can help you meet FDA’s requirements.

Respirators Eligible for Authorization under this EUA
**(non-Chinese) [See information about Chinese manufactured non-NIOSH-approved respirators at the end of this blog.]

1. Disposable FFRs that have been designed, evaluated, and validated to meet a given performance standard and have corresponding acceptable product classifications, as follows:

Jurisdiction1	Performance Standard	Acceptable product classifications	Standards/ Guidance Documents	Protection Factor ≥ 10
Australia	AS/NZS 1716:2012	P3, P2	AS/NZS 1715:2009	YES
Brazil	ABNT/NBR 13698:2011	PFF3, PFF2	Fundacentro CDU 614.894	YES
Europe	EN 149-2001	FFP3, FFP2	EN 529:2005	YES
Japan	JMHLW-2000	DS/DL3 DS/DL2	JIS T8150: 2006	YES
Korea	KMOEL-2017-64	Special 1st	KOSHA GUIDE H-82- 2015	YES
Mexico	NOM-116-2009	N100, P100, R100, N99, P99, R99, N95, P95, R95	NOM-116	YES

¹ Canada is not listed because it allows self-declaration to NIOSH or equivalent standards.

2. Disposable FFRs which have a marketing authorization in one of the following regulatory jurisdictions:

• European CE Mark
• Australian Register of Therapeutic Goods (ARTG) Certificate of Inclusion
• Health Canada License
• Japan Pharmaceuticals and Medical Device (PMDA)/Ministry of Health Labour and Welfare (MHLW)

HOW Do You Take Advantage of This? 

Manufacturers and/or importers must send a request to FDA by email of their intent to import non-NIOSH-approved disposable respirators that are eligible for authorization under 1 and/or 2 above. The manufacturer or importer should send a request to be authorized under this EUA by email to FDA with the following information, which will allow FDA to determine whether the
disposable respirator meets the criteria to be added to the EUA authorized respirator list:

• Specify the manufacturer, model number(s), marketing authorization/certificate from another regulatory authority or conformity assessment body acting on their behalf (including the authorization number (if any)), certificate of conformity (if available), applicable performance standards that their product meets, and any applicable guidance documents.
• An estimate of the number of respirators you are planning to import during the public health emergency,
• A copy of the product labeling. Respirators must comply, at a minimum, with the labeling requirements in conditions A and B under the Conditions of Authorization (Section IV) of this letter.

Once FDA receives the above information, and any additional information it needs to confirm applicability of the imported disposable respirator with eligibility under the categories outlined above, FDA will notify the manufacturer of the inclusion of their authorized respirator(s) in Exhibit 1 under this EUA by replying to the manufacturer’s or importer’s email.

Conditions of Authorization: THESE are ADDITIONAL STEPS. There are some steps that the manufacturer must complete and then tell FDA that they did so.

Manufacturers of Authorized Respirators:

A. Manufacturers of authorized respirators are required to publish the intended use and other instructions (such as fit testing, etc.) about all authorized models that are imported and authorized under this EUA on their website in English. Additionally, manufacturers must notify FDA by emailing FDA with the website address (URL) that meets this condition. FDA will make this information available to the public on its EUA website at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ppe. Manufacturers must notify FDA of any changes to this webpage.

B. Manufacturers must prepare and include a letter, in English, that can be distributed to each end-user facility (e.g., each hospital, etc.) that receives the authorized respirator model. This letter must include the authorized respirator’s manufacturer, model, intended use, manufacturer’s webpage (if applicable), etc.

C. Manufacturers of authorized respirators will notify the importer (if applicable) of the terms and conditions of this EUA and ensure that the end user facility (e.g., each hospital, etc.) that receives the authorized respirators also receives the information required under Condition B.

D. Manufacturers of authorized respirators will have a process in place for reporting adverse events of which they become aware and send such reports to FDA. {There is a requirement for manufacturers to tell FDA anything about this item. The manufacturer just has to comply.]

E. All descriptive printed material relating to the use of the authorized respirators in the United States shall be consistent with applicable CDC recommendations for use during the COVID-19 outbreak, as well as the terms set forth in this EUA. [There is nothing to report to FDA directly, the manufacturer (or importer) just has to make sure it is done. This is just an extension of B.]

F. No descriptive printed matter relating to the use of the authorized respirators in the United States may represent or suggest that the product is safe or effective for the prevention of COVID-19.  [There is nothing to report to FDA directly, the manufacturer (or importer) just has to make sure it is done. This is just an extension of A, B and E, above.]

G. Manufacturers of authorized respirators will ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon request. [Again, nothing to report to FDA, they just have to keep records of what they did to comply with A-F and records of what they exported to the USA.]

Importers:

H. All descriptive printed material relating to the use of the authorized respirators shall be consistent with applicable CDC recommendations for use during the COVID-19 outbreak, as well as the terms set forth in this EUA. [Duplicate of E.]

I. No descriptive printed material relating to the use of the authorized respirators may represent or suggest that the product is safe or effective for the prevention of COVID-19. [Duplicate of F.]

J.  Importers of authorized respirators will notify manufacturers of the terms and conditions of this EUA and ensure that the end user facility (e.g., each hospital, etc.) that receives the authorized respirators also receives the information required under Condition B.  [Reciprocal to C – and not difficult if the importer is helping the manufacturer.]

K. Importers of authorized respirators will ensure that any records associated with this EUA are maintained until the end of this public health emergency. [Importer version of G.]

Update 04/13/2020
FDA recently created a pathway for (the now infamous) Chinese KN95 Respirators to be EUA approved

For disposable non-NIOSH-approved face masks from China to be approved under the EUA, they must meet one of these criteria.

1. The manufacturer holds one or more NIOSH approvals for other models of filtering facepiece respirators (FFRs)
2. The manufacturer has a regulatory authorization from a non-Chinese jurisdiction that FDA can verify
3. The mask meets performance standards based on test reports from a recognized independent test laboratory

Once FDA confirms eligibility, the manufacturer will be added to the authorized respirators list on  Appendix A.

Our team of regulatory consultants and affiliated attorneys can help manufacturers and importers meet all FDA requirements outlined above. Contact us today to get started.