FDA Guidance Expands Regulatory Requirements for Face Masks and Respirators

April 7, 2020Alerts

As the COVID-19 pandemic continues to overwhelm the country’s healthcare resources, the Food and Drug Administration (FDA) has actively been revising its regulatory requirements to meet public health concerns. On April 3, 2020, the FDA issued new guidance to expand the availability of general use face masks and certain filtering respirators (April Guidance) superseding earlier guidance issued just a few weeks earlier in March.

The April Guidance reiterates that the FDA does not intend to object to the distribution and use of face masks that do not create an "undue risk" in light of the current public health emergency. Noncompliance with the typical premarket regulatory requirements under section 510(k) of the Food, Drug and Cosmetic Act will be waived. One such waived requirement is the Registration and Listing requirements provided in 21 CFR 807. Nevertheless, the FDA recommends proper labeling and the inclusion of adequate disclaimers to inform the consumer of the products’ limits. 

Similarly, the FDA does not intend to object to the distribution of Class II surgical masks that provide a physical barrier to fluid and particulate matters and are tested for flammability and biocompatibility for the duration of the public health emergency, so long as such device does not create an undue risk by meeting certain fluid resentence and flammability requirements.

With respect to respirators, the FDA defers to the manufacturers and distributor to confirm authenticity of the respirator’s design during the present public health emergency, and has elected not to object to the distribution and importation of such products that the Center for Disease Control (CDC) recommends as being a part of the current crisis management options. It is important to note that importers bringing such equipment will be doing so at their own risk, and will not have the customary protections as if they were normally certified devices by the FDA.

FDA still encourages the manufacturers and distributors to engage the FDA before importing non-NIOSH-approved N95 respirators. The March Guidance cleared the path under applicable Emergency Use Authorization (EUA) for marketing of devices that may have obtained authorization from Australia, Brazil, Europe, Japan, Korea and Mexico who have similar standards to NIOSH. However, the FDA has not included KN95 respirators made per China’s standards on the list because of growing concerns about fraudulent products listed as KN95s. Such products may be eligible for authorization if certain evidence demonstrating that the respirator is authentic. Gathering such evidence prior to market entry is recommended during a proper due diligence review of such products.

Following public outcry for more clarity on the legality of importing KN95 masks, the Deputy Commissioner for Medical and Scientific Review, Anand Shah, stated that the FDA would not be blocking KN95 importations. Soon after, the FDA updated their FAQs and provided that during the duration of the pandemic, and when FDA-cleared or NIOSH-approved N95 respirators are not available, the FDA is not likely going to object to the importation and use of respirators without an EUA, including KN95 respirators, if they are on the Centers for Disease Control and Prevention (CDC) list of respirator alternatives during the COVID-19 pandemic. Although the FDA will not require a EUA, they encourage importers to take appropriate steps to verify authenticity, specifically because of concern regarding concerns of fraudulent products. The FDA has also emphasized their willingness to work with importers to minimize any disruptions during the importing process.

For any further questions or clarifications, please contact Shahnam Sharareh at [email protected] or 609.844.3030, and Nawa Lodin at [email protected] or 212.878.7969 to discuss your specific scenarios.