The Center for Devices and Radiological Health (CDRH) issued a revised guidance describing its policy on enforcement strategy for public personal use and filtered healthcare professional face masks titled Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (here). The CDRH says the relaxed policy will remain in effect only until the public health emergency related to COVID-19 is over.
The FDA took this action to improve the availability of protective face masks during the COVID-19 pandemic in response to shortages felt nationwide, both for healthcare professionals and the general public. With an army of individuals and companies trying to jump in to lessen the shortage and meet demand, the CDRH has taken this extraordinary action. Please note that, in the context of the definition of face masks, the CDRH indicates that face masks used for a medical purpose are regulated, but others that are not are not considered medical devices, nor do they require clearance. The Agency discusses this difference in greater detail in the guidance.
The Agency is quick to note that the relaxed policy does not apply to certain other types of facemasks that the CDRH lists in Table 2 of the guidance; for example, oxygen or anesthetic gas masks and gas masks intended to protect from exposure to a noxious gas, among others.
But for medical use, masks that it identifies in Table 1 of the document, the “FDA does not intend to object to individuals’ distribution and use of improvised PPE when no alternatives, such as FDA-cleared masks or respirators, are available.” The revised guidance goes on to describe in detail what is covered by the policy, temporarily relaxing enforcement, and what is not covered by the policy. The FDA also outlines the potential need to verify the authenticity of certain face masks that are critical in the care of patients during this emergency to best ensure protection of both healthcare providers and the patients themselves.
Please read the guidance document carefully to ensure that any actions taken are in compliance with the policy. For questions relative to this guidance, please contact Lachman Consultants at LCS@LachmanConsultants.com for further advice.