Perspective on Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency

April 1, 2020

By Manuel Garza, Principal Consultant, Compliance

In summary

FDA is moving quickly to implement emergency use applications (EUAs) policy to provide flexibility to those manufacturers of face masks and respirators to meet the need of medical practitioners and consumer demands.

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The COVID-19 pandemic has seriously impacted our healthcare system and the demand for face masks and respirators has overrun the capacity of the domestic and global manufacturing capacity and has placed patients and the medical community at risk.  There is an immediate need and demand for face masks and respirators that can be easily and reliably deployed.  Recently in the virtual, printed and televised press, numerous companies have been augmenting their production processes and product workstreams to produce face masks and respirators.  The manufacturers vary from medical device companies to companies not in the medical field retooling and converting to manufacture these required face masks and respirators. 

The challenge for these manufacturers is their varied and diverse nature, their facility controls, and their capabilities to consistently produce a product intended for medical purposes while not creating an undue risk in light of the public health emergency. This was likely the impetus for the FDA to create and implement an enforcement policy for face masks and respirators without a commentary period.

The following talking points provide a high-level synopsis of the enforcement policy intended to remain in effect only for the duration of the public health emergency:

Enforcement Policy for Face Masks and Respirators During the COVID-19 Public Health Emergency - March 2020

  • The Agency is issuing the guidance to provide a policy to help expand the availability of general use face masks for the general public and particulate filtering facepiece respirators (including N95 respirators) for health care professionals during this pandemic. 
  • It will remain in effect only for the duration of the public health emergency declared by the Secretary of Health and Human Services on January 31, 2020. 
  • After which, FDA intends to discontinue this enforcement discretion policy and withdraw this guidance. 
  • Face masks and respirators are regulated by FDA when they meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Generally, face masks fall within this definition when they are intended for a medical purpose, including for use by health care professionals. 
  • FDA is taking steps to expand the availability of face masks and respirators and believes the policy may help address the urgent public health concerns caused by shortages of such products by taking a risk-based approach and clarifying the policies that FDA intends to apply to masks and respirators not intended for medical purposes, such as use in construction and other industrial applications. 

Face Masks and N95 Respirators Not Intended for a Medical Purpose

  • When considering whether these products are intended for a medical purpose, among other considerations, FDA will look at whether:
    • they are labeled or otherwise intended for use by a health care professional;  
    • they are labeled or otherwise intended for use in a health care facility or environment; and
    • they include any drugs, biologics, or anti-microbial/anti-viral agents.

Face Masks Intended for a Medical Purpose that are NOT Intended to Provide Liquid Barrier Protection  

  • FDA currently believes such devices would not create an undue risk where:
    • The product includes labeling that accurately describes the product as a face mask (as opposed to a surgical mask or FFR) and includes a list of the body contacting materials (which does not include any drugs or biologics);
    • The product includes labeling that makes recommendations that would reduce sufficiently the risk of use, for example, recommendations against: use in any surgical setting or where significant exposure to liquid, bodily or other hazardous fluids, may be expected; use in a clinical setting where the infection risk level through inhalation exposure is high; and use in the presence of a high intensity heat source or flammable gas; and
    • The product is not intended for any use that would create an undue risk, for example the labeling does not include uses for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses and does not include particulate filtration claims. 

Surgical Masks Intended to Provide Liquid Barrier Protection

  • FDA currently believes such devices would not create an undue risk where:
    • The product 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); 
    • The product 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); 
    • The product includes labeling that accurately describes the product as a surgical mask and includes a list of the body contacting materials (which does not include any drugs or biologics); and 
    • The product is not intended for any use that would create an undue risk, for example the labeling does not include uses for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses, and does not include particulate filtration claims.

FDA’s Intended Approach for EUAs for Masks and Respirators

  • Emergency Use Authorizations (EUAs) for Reprocessing of Filtering Facepiece Respirators
    • FDA is interested in interacting with manufacturers on the reprocessing of otherwise disposable N95 particulate filtering facepiece respirators (and other Filtering Facepiece Respirators) to facilitate marketing authorization through an emergency use authorization (EUA) for reprocessed devices.
    • FDA recommends that firms contact FDA and provide the following information to CDRH-COVID19-SurgicalMasks@fda.hhs.gov, if available. FDA will work with reprocessors through its EUA process to facilitate expedited evaluation of the request. To help facilitate the pre-EUA discussions, we recommend that you send FDA as much of the following information you have available: 
      • A description of the process for disinfection/reprocessing controls
      • Validation of bioburden reduction/disinfection
      • Description of chain of custody and safeguards to prevent inadvertent exposure
      • Material compatibility
      • Filtration performance
      • Fit test data
      • A copy of the reprocessed device product labeling 
  • EUAs for Face Masks Intended for a Medical Purpose, Surgical Face Masks and N95 Respirators
    • FDA has also issued EUAs that authorize certain N95 Filtering Facepiece Respirators, including NIOSH-approved disposable FFRs and imported non-NIOSH-approved disposable FFRs, for use in healthcare settings by healthcare personnel and are intended to help increase availability of these devices to front-line personnel during the public health emergency.
    • FDA is interested in interacting with manufacturers on additional device-specific EUAs. This may include manufacturers of masks and respirators that are not currently legally marketed in the US as well as manufacturers who have not previously manufactured masks or respirators with capabilities to increase supply of these devices.
    • FDA would find it helpful if such manufacturers (whether foreign or domestic) send FDA the following information to CDRH-COVID19-SurgicalMasks@fda.hhs.gov; FDA believes this information will be valuable in assessing whether the device would be able to meet the EUA requirements.
    • For any face mask or filtering facepiece respirator (including N95 respirators) issued an EUA, FDA will include appropriate conditions of authorization in accordance with section 564 of the FD&C Act, including the following: 
    • Appropriate conditions for the monitoring and reporting of adverse events associated with the emergency use of the device. FDA intends to include conditions that are consistent with those promulgated under 21 CFR Part 803. 
    • For manufacturers of the device, appropriate conditions concerning recordkeeping and reporting, including records access by FDA, with respect to emergency use of the device.

 

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