US FDA Issues Revised Face Mask and Respiratory Enforcement Policy
The US FDA has issued “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)” May 2020. This revision includes updates regarding alternatives when FDA-cleared or NIOSH-approved N95 respirators are not available.
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The US Food and Drug Administration (FDA) has issued a revised “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)”.
Applicable products under the enforcement policy include respirators, face masks, face shields “intended for a medical purpose”, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. Items marketed to the general public for general, non-medical purposes, such as use in construction and other industrial applications do not fall within the scope of the enforcement policy.
The FDA believes the policy set forth in the guidance may help address these urgent public health concerns by clarifying the regulatory landscape of face masks and respirators, helping to expand the availability of general use face masks for use by the general public, and of filtering facepiece respirators (including N95 respirators) for use by HCP in healthcare settings.
This revision supersedes the guidance, “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised),” issued in April 2020. The April 2020 version revised the original guidance, “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency,” issued March 25, 2020, to include face shields and to provide FDA’s recommendations regarding alternatives when FDA-cleared or NIOSH-approved N95 respirators are not available.
Critically, the revised enforcement policy includes updates regarding alternatives when FDA-cleared or NIOSH-approved N95 respirators are not available.
Detail of the change of alternatives to FDA-cleared or NIOSH approved N95 Respirators
In the April 2, 2020 publication of this guidance, the FDA provided flexibility regarding distribution and use of respirators identified in the Centers for Disease Control and Prevention (CDC) recommendations without compliance to certain regulatory requirements, including submission of a 510(k) under certain circumstances.
In addition to this policy, and in response to the shortage of respirators, the FDA issued emergency use authorizations (EUAs) for certain respirators that it determined met the criteria for issuance under Section 564 of the Act.
Since the April 2, 2020 publication of this guidance, the FDA has become aware of concerns regarding the performance of certain respirators based on testing conducted by the CDC. This indicates that greater FDA oversight of respirators that are not FDA-cleared or authorized under an EUA is important to protect the public health.
As a result of these changed circumstances, the FDA is discontinuing its previous policy from April 2, 2020 under which it did not intend to object to the distribution and use of certain respirators that were not FDA-cleared or authorized under an EUA and did not meet other regulatory requirements.
The FDA currently believes that FDA-cleared or NIOSH-approved N95 respirators should be used when they are available, but when they are not, it recommends using FDA-authorized respirators before any other alternatives This is consistent with the CDC’s approach for optimizing the supply of N95 respirators. The FDA does not recommend using a product as a respirator unless it has been FDA-cleared, NIOSH-approved, or authorized by them for emergency use as a respirator.
Such a product could instead be used as a face mask by the general public and HCP as source control when certain criteria are met under the EUA for face masks. In that case, the product should be labeled accordingly and not used as a respirator. FDA EUA for Face “Source Control” Facemasks: https://www.fda.gov/media/137121/download.
Furthermore, the revision removes the FDA’s prior recommendations regarding emergency use authorizations (EUAs) for decontamination of face masks and filtering facepiece respirators. Concurrently with issuance of this revised guidance, the FDA is issuing the guidance, “Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Surgical Masks and Respirators During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”
FDA’s use of Enforcement Policies an EUAs
The FDA use enforcement policies and EUAs to expand the use of expand the availability of medical personal protective equipment. The policies outlined in enforcement policies and EUAs are only effective for the duration of a declared public health emergency (e.g. COVID-19).
During a public health emergency, the FDA can use its Emergency Use Authorization (EUA) authority to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.
Enforcement policies do not establish legally enforceable responsibilities. Instead, guidance describes the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
The FDA has released EUAs and enforcement policies for several medical PPE items in addition to face masks and respirators, including gowns, gloves, face shields etc.
FDA Emergency Use Authorizations (EUAs) can be found on the FDA website:
FDA Enforcement Policies can be found on the FDA website:
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised – May 2020)
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