Not So Fast – FDA Retracts Authorization for Some Respirators Made in China

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Immunity under the Public Readiness and Emergency Preparedness (“PREP”) Act is a moving target for government contractors and other companies manufacturing or distributing personal protective equipment (PPE) in the COVID-19 public health response. We wrote previously about new liability protections afforded to manufacturers and distributors of certain face masks approved by National Institute for Occupational Safety and Health (“NIOSH”) through the Families First Coronavirus Response Act, and the later expanded scope of that protection provided by the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act and amended PREP Act declaration by Department of Health and Human Services. Until recently, the list of devices eligible for liability immunity seemed to be continuously growing as the COVID-19 public health response required more and more PPE. But last week, the Food and Drug Administration (“FDA”) took a significant step back, retracting its Emergency Use Authorization (“EUA”) for respirators from 75 manufacturers in China, which previously had been approved for use in the response to COVID-19. This retraction has the additional effect of disqualifying government contractors, and other companies that distribute newly unauthorized respirators, from PREP Act immunity in connection with these devices.

Under the PREP Act, manufacturers and distributors of covered countermeasures, which include certain respirators (a type of filtering face mask) are eligible for immunity from suits for injury, death, and some other losses stemming from use of the covered countermeasures in the government response to a public health emergency. One way medical devices may qualify as covered countermeasures, even if they were not previously FDA-approved or -cleared, is if they are subject to an EUA by the FDA. The FDA issued multiple EUAs beginning in March 2020, temporarily approving the use in healthcare settings of various respirators either meant for occupational use or imported and validated under foreign government health standards. The list of respirators the FDA has approved under EUAs is available on the FDA’s website as Appendix A. The FDA issued the most recent respirator EUA on April 3, 2020, authorizing certain respirators made in China, despite uncertainty regarding whether these respirators met the FDA’s threshold requirements for effective protection against COVID-19.

The FDA walked back its authorization for many of these devices on May 7, 2020. In response to NIOSH laboratory tests showing some respirators did not meet the 95% particulate filtering standard required for EUA eligibility, as well as unspecified concerns shared with the FDA, the FDA revised its April 3 EUA and removed nearly eight pages of respirator models from its authorized respirator list in Appendix A.

For hospitals, this means that the FDA no longer approves using these respirators in treating COVID-19 patients (or for any other use). For distributors of these respirators, it means that any potential liability protection under the PREP Act has likely been eliminated. Distributors with plans to sell or donate disqualified masks to federal, state, or local COVID-19 response efforts should beware that, unless these respirators are re-listed in Appendix A or approved under a revised FDA EUA, they likely will not qualify as covered countermeasures under the PREP Act.

The revised EUA also both established a procedure for the FDA to remove more respirators from Appendix A if necessary in the future, and changed the criteria slightly for additions to Appendix A. The FDA stated that it plans to continue testing imported respirators, and any respirators found not to meet the applicable standards will be removed from Appendix A and added to the list of unauthorized respirators now available on the FDA website. Distributors and other government contractors selling or donating imported respirators should monitor this list regularly for changes. We will continue to monitor and share these developments through our blog.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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