FDA Update – Non-NIOSH Approved Disposable Filtering Facepiece Respirators (FFR)

WELL no surprise – this COVID-19 Mask situation is very fluid and the FDA has made another update on what they are allowing to be labeled as a FFR Mask that are not NIOSH approved.

The USA is being the WILD WILD WEST when it is related to the FACE MASK marketing. Not surprising – when you see just about anyone and everyone is trying to manufacture and.or import MASKS. Everyone wants to use the very important FFR claim with the minimum testing. And every governor, mayor, hospital is claiming shortage and is looking for MASKs MASKs – MASKs.

No matter how important it is to get REAL suppliers of these masks, the FDA could keep up with the EUA applications. They needed to put more clarity on what they needed to approve this applications and what is a SAFE mask.

On May 7, 2020, the FDA is reissuing the April 3, 2020 EUA with certain revisions to authorize disposable respirators manufactured in China that meet certain criteria, including criteria concerning additional validation and review by the FDA to confirm the respirator’s authenticity. The key changes for respirators eligible to the EUA are as follows:

• Revising the eligibility criterion for 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;
• Adding recognition of the Chinese National Medical Products Association (NMPA) registration certification, under criterion two of the revised EUA
• Amending the Scope of Authorization to describe a process FDA will use in removing respirators from Appendix A if FDA has reason to believe that the respirator is no longer eligible for authorization.

In order for your FFR to be added to Appendix A as an authorized respirator, one of the following criteria must be met:

1. It is 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; or
2. It has a regulatory authorization under a jurisdiction, including the Chinese National Medical Products Administration (NMPA) registration certification by an appropriate provincial or municipal regulatory authority, that can be authenticated and verified by FDA; or
3. It was previously listed in Appendix A under the April 3, 2020 letter of authorization as an authorized respirator because it demonstrated acceptable performance to applicable standards as documented by test reports, has had particulate filtration efficiency assessed by NIOSH using a modified version of NIOSH’s Standard Test Procedure (STP) TEB-APR-STP-0059 within 45 calendar days of the date of issuance of this EUA, and has results of NIOSH testing that indicate a minimum and maximum filtration efficiency greater than or equal to 95 percent.

While meeting the above criteria, additional information along with a request to FDA with the subject “FFRS Made in China” to CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov with the information need per each criteria:

1. For respirators meeting criterion #1 above, please provide:
   1. The manufacturer contact information (name, address, contact person, phone number, and email), model number and NIOSH approval numbers for your NIOSH approved respirator(s)
   2. The manufacturer name, address, model number, and a copy of the product labeling for the respirator you want authorized
   3. An estimate of the number of respirators you are planning to import during the public health emergency
   4. A list of authorized importer(s) including contact information (name, address, contact person, phone number, and email)
2. For respirators meeting criterion #2 above, please provide:
   1. The manufacturer contact information (name, address, contact person, phone number, and email), model number, and a copy of the product labeling for the respirator you want authorized
   2. Marketing authorization document/certificate from another regulatory authority or conformity assessment body acting on their behalf (including the authorization number and the name of the conformity assessment body)
   3. Certificate of conformity to the applicable standards
   4. An estimate of the number of respirators you are planning to import during the public health emergency
   5. A list of authorized importer(s) including contact information (name, address, contact person, phone number, and email)
3. For respirators meeting criterion #3 above, within 45 calendar days of the reissuance of the EUA, please provide:
   1. The manufacturer contact information (name, address, contact person, phone number, and email), model number, and a copy of the product labeling for the respirator you want authorized
   2. Weblink which displays the results of your NIOSH test report
   3. A list of authorized importer(s) including contact information (name, address, contact person, phone number, and email)
   4. An estimate of the number of respirators you are planning to import during the public health emergency

FDA will sample respirators from already imported lots of respirators under criterion #3. If a manufacturer has not shipped respirators to the United States at the time of this EUA is reissued, the FDA will work with a manufacturer who is eligible for criterion #3 in order to sample respirators once they arrive at a US port of entry.

Based on the revised May 7, 2020 EUA, in order to be added to Appendix A, you may submit information demonstrating that your respirator(s) meet the applicable criteria in the reissued EUA as described above. Criterion #3 is not applicable to your respirator(s) because your respirator(s) were not previously listed in Appendix A. As a reminder, importers may no longer request authorization.

Please make note that if your respirator model(s) do not meet the EUA criteria reissued on May 7, 2020, your product(s) may meet the eligibility criteria for authorization under the Face Masks (non-surgical) EUA. Additionally, during COVID-19, FDA generally does not intend to object to the importation and use of a respirator model outside of healthcare settings, as a general face mask, as described in FDA’s guidance document entitled  Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency.

mdi is presently working with many companies who want to obtain the FDA EUA. If you need assistance with obtaining the authorization of your FFRs as well as any questions you make have regarding the reissuance of this EUA, please email us. For any further questions regarding this EUA, please feel free to email info@mdiconsultants.com RE: Filtering Facepiece Respirator.