June 23, 2020

FDA Revises Enforcement Policy for Face Masks and Respirators

On May 26, 2020, the United States Food and Drug Administration (FDA) revised its Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, which supersedes the version issued on April 2, 2020.

The May 26 Enforcement Policy revokes FDA’s previous statements that it would not object to the use of certain respirators that were not FDA-cleared or FDA-authorized under an Emergency Use Authorization (EUA) and did not meet other regulatory requirements. Under this new policy, FDA indicated that FDA-cleared or National Institution of Occupational Safety and Health (NIOSH)-approved N95 respirators should be used when available. If these are not available, FDA recommends using FDA-authorized respirators before any alternatives.

FDA does not recommend using a product as a respirator unless it has been NIOSH-approved, FDA-cleared or authorized by the FDA for emergency use as a respirator. Products, such as non-authorized respirators made in China, should be used as a face mask (or face covering) by the general public as a form of source control as indicated in the general use (non-surgical) face mask EUA. In that case, the product should not be labeled or promoted as a respirator.

FDA is continuing other elements of the previous Enforcement Policy regarding face masks for a medical purpose that are not intended to provide liquid barrier protection, face shields intended for a medical purpose and surgical masks intended to provide liquid barrier protection. So long as these products do not create undue risk, FDA does not intend to object to distribution or use of such products even though these are not in compliance with 510(k) premarket notification, registration and listing requirements (21 CFR 807), quality system regulations (21 CFR 820), reports of corrections and removals (21 CFR Part 806) and Unique Device Identification requirements (21 CFR 801.20, 830).

Please refer to the full enforcement policy for a complete list of criteria FDA believes these products should meet in order to not create undue risk. As a reminder, FDA does not regulate face masks, face shields and N95 respirators not intended for a medical purpose.

Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.

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