FDA Issues Updated Guidance Relating to its Enforcement Policy for Face Masks and Respirators

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The US Food and Drug Administration (FDA) issued updated guidance superseding its earlier March 25, 2020, “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)” (Updated Guidance). FDA is taking steps to expand the availability of face masks and respirators to 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, including the products’ associated indications and claims.

Face masks, face shields, and N95 respirators are considered devices intended for a medical purpose, as set forth under section 201(h) of the Food Drug and Cosmetic Act, when they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease (including uses related to COVID-19).[1] When evaluating whether these products are intended for a medical purpose, among other considerations, FDA will consider whether: (1) they are labeled or otherwise intended for use by a health care professional; (2) they are labeled or otherwise for use in a health care facility or environment; and (3) they include any drugs, biologics, or anti-microbial/anti-viral agents.

For the duration of the public health emergency, and provided that certain devices do not create an undue risk, FDA is relaxing certain regulatory compliance requirements relating to face masks, face shields[2] and surgical masks as follows:

For the following device(s):

• Face Masks Intended for a Medical Purpose that are NOT Intended to Provide Liquid Barrier Protection
• Surgical Masks Intended to Provide Liquid Barrier Protection
• Certain Respirators, (when FDA cleared or NIOSH-approved N95 respirators are not available)

The FDA is relaxing the following regulatory requirements:

• Prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81;
• Registration and Listing requirements in 21 CFR Part 807;
• Quality System Regulation requirements in 21 CFR Part 820, reports or corrections and removals in 21 CFR Part 806; and
• Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20.

For face shields intended for a medical purpose, the FDA is relaxing the following regulatory requirements:

• Registration and Listing requirements in 21 CFR Part 807;
• Quality System Regulation requirements in 21 CFR Part 820, reports or corrections and removals in 21 CFR Part 806; and
• Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20.

In evaluating the above devices, FDA believes such devices would not create an undue risk in light of the public health emergency under the following circumstances.

Where the device is a face mask intended for a medical purpose that is not intended to provide liquid barrier protection, FDA guidance on not creating undue risk is:

• The product includes labeling that accurately describes the product as a face mask (as opposed to a surgical mask or FFR [filtering facepiece respirator]) 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 in improper settings, such as: 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 in light of the public health emergency, 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.

Where the device is a face shield intended for a medical purpose, FDA guidance on not creating undue risk is:

• The product includes labeling that accurately describes the product as a face shield and includes a list of the body contacting materials (which does not include any drugs, or biologics);
• The face shield does not contain any materials that will cause flammability, or 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); and
• The product is not intended for any use that would create an undue risk in light of the public health emergency, 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, or for radiation protection.

Where the device is a surgical mask intended to provide liquid barrier protection, FDA guidance on not creating undue risk is:

• The product meets fluid resistance testing (liquid barrier performance) consistent with standard ASTM F186211 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 in light of the public health emergency, 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.

 It is worth noting as outlined above, the labeling requirements and requisite fitness and safety requirements are not the same for facemasks, face shields, and surgical masks. 

Finally, the Guidance also outlines FDA’s intended approach for Emergency Use Authorization (EUA) for Decontamination of Face Masks and Filtering Facepiece Respirators and for Face Masks Intended for a Medical Purpose, Surgical Face Masks and N95 Respirators.

As the COVID-19 crisis evolves, Seyfarth Shaw attorneys are closely monitoring FDA’s reactions to the situation. We are available to protect your interests, help you mitigate risks and liabilities, and keep you informed regarding the latest implications related to the COVID-19 crisis. Visit our COVID-19 Resource Center for more information.

 

[1] FDA device marketing authorization is not required, and all the other requirements of the FD&C Act do not apply to manufacturers, importers, and distributors of products intended for non-medical purposes.

[2] Face shields protect the user’s eyes and face from liquid splashes, bodily fluids, and potentially infectious materials.  Face masks cover the user’s nose and mouth and provide a physical barrier.

[3] When FDA cleared or NIOSH-approved N95 respirators are not available, FDA does not intend to object to the distribution (including importation) and use of respirators identified in the CDC recommendations. For CDC recommendations, please review https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/crisis-alternate-strategies.html. FDA also recommends that importers take appropriate steps to verify the authenticity of the products they import.