FDA Lifts Requirements for Masks, Respirators, Looks to Reprocessing to Ease Shortages

Regulatory NewsRegulatory News | 26 March 2020 |  By 

As the supply of critical personal protective equipment (PPE) dwindles amid the coronavirus disease (COVID-19) pandemic, the US Food and Drug Administration (FDA) is lifting requirements for certain masks and respirators to increase their availability.
In a 10-page guidance explaining its enforcement policy for masks and respirators used during the COVID-19 public health emergency, FDA explains what regulatory requirements it is lifting for different types of masks and explains its expectations for emergency use authorizations (EUAs).
FDA points out that face masks and respirators intended for general or industrial use and not intended for medical purposes are not considered medical devices and thus not subject to requirements under the Federal Food, Drug, and Cosmetic Act.
For face masks intended for a medical purpose that are not intended to provide liquid barrier protection, FDA says it is lifting major regulatory requirements to increase availability of the devices, including 510(k) submission, quality system regulation (QSR), registration and listing, and unique device identifier (UDI) requirements, so long as the devices do not create an undue risk for users.
FDA says it will allow the distribution and use of surgical masks, which are Class II devices, without 510(k) clearance, given that the masks meet certain standards for fluid resistance and flammability and include accurate labeling.
The agency also says it is interested in allowing companies to disinfect and reprocess otherwise disposable N95 respirators to stretch the supply of the devices under an emergency use authorization (EUA).
Typically, reprocessors must obtain 510(k) clearance to reprocess single use devices. However, given the urgent need for respirators, FDA says it will work with companies to expedite the EUA process and provides a detailed list of information for companies to provide to support an EUA request.
The policy comes as US agencies push recommendations to conserve the supply of PPE as physicians and health care workers around the country report resorting to improvised and homemade masks. So far this month, FDA has issued two broad EUAs to allow the use of National Institute for Occupational Safety and Health (NIOSH) approved and imported non-NIOSH approved respirators in an effort to boost their supply.
In the last week, some hospitals have said they are looking into reprocessing N95 respirators on their own, including the University of Iowa Hospitals and Clinics and the University of Nebraska Medical Center.
The relaxed policies only apply to specific types of masks and respirators that fall under seven product codes and do not apply to other masks intended for specific uses, such as masks used in anesthesiology.


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