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FDA Releases New Enforcement Policy for Face Masks and Respirators

April 7, 2020

On April 2, the U.S. Food and Drug Administration (FDA) issued updated guidance 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 (HCPs) during the ongoing Coronavirus Disease 2019 (COVID-19) emergency.

The guidance does three key things:

First, FDA recognizes that when FDA-cleared masks or respirators are unavailable, individuals, including HCPs, might improvise PPE. To help foster the availability of equipment that might offer some benefit to HCPs and the general public during the COVID-19 emergency, FDA has loosened normally applicable regulations and will allow manufacturers to market non-medical face masks for a medical purpose so long as the face mask does not create an undue risk in light of the public health emergency.

Second, to facilitate the safe reuse and conservation of PPE for a medical purpose, FDA expressed interest in interacting with manufacturers on the decontamination of otherwise disposable face masks and filtering facepiece respirators to facilitate marketing authorization through an Emergency Use Authorization (EUA) for new decontamination devices.

Third, to further increase supply of face masks, FDA also expressed interest in interacting with manufacturers of face masks, surgical face masks, N95 respirators, and devices that do not fall within the scope of the recently issued FDA EUAs. This may include manufacturers of masks and respirators that are not currently legally marketed in the United States as well as manufacturers who have not previously manufactured masks or respirators.

The recent guidance reflects how the FDA is adapting to the COVID-19 emergency. The guidance states the FDA is looking to expand the availability of general use face masks for the general public and particulate filtering facepiece respirators for HCPs during this emergency.

Businesses should, nonetheless, take steps to mitigate litigation risks associated with distributing masks to the general public. Appropriate disclaimers and warnings should be provided on the mask labeling to make clear that the face masks are, at a minimum:

  • Intended for general, non-medical, purposes.
  • Not intended for use by health care professionals.
  • Not intended for use in a health care facility or environment.

Additional warnings may be needed. To address the current need for Personal Protective Equipment (PPE) the FDA hosted a public webinar on April 6, targeting medical device companies, distributors, and technology manufacturers.

For more information, please contact the professional(s) listed below, or your regular Crowell & Moring contact.

John Fuson
Partner – Washington, D.C.
Phone: +1.202.624.2910