Bringing Face Masks to Market

Update 06/10/2020

On June 6, 2020, the FDA made several changes to EUAs for certain N95 respirators and Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. FDA issued EUAs for products used to decontaminate certain N95 respirators for multiple-user reuse by HCP.  Based on testing conducted by the CDC NIOSH on respirators made in China, FDA has now determined that, generally, authorized respirators made in China would not be authorized after decontamination. 

Update 05/07/2020

FDA issued a revised Emergency Use Authorization (EUA) for “disposable filtering facepiece respirators (FFR) manufactured in China that do not meet NIOSH standards.” This comes as a result of questions about the ability of the respirators to meet a minimum particulate filtration efficiency of 95% when testing by NIOSH. 

Note: This blog was updated 04/13/2020 to reflect new FDA guidance.

Previously edited 3/24/2020 based on FDA guidance updates.

With face mask shortages in the United States, and worldwide, many manufacturers and distributors are looking to import and distribute new supplies of face masks. We encourage you to read our Face Mask Warning blog, which describes which mask meets which standards.

Here is a brief overview of the current regulatory requirements for the different types of masks which can be brought to market in the U.S. 

1. Disposable surgical masks are always FDA Class II devices, which require 510(k) clearance prior to importation and marketing in the US. This includes masks for use in sterile and non-sterile fields. In conjunction with meeting 510(k) requirements, there are labeling, facility registration, product listing, and U.S. Agency requirements to consider. FDA has offered expedited processes for obtaining 510(k)s for surgical masks during the COVID-19 pandemic. FDA has also created an alternative pathway via the use of Emergency Use Authorizations (EUA), which we describe more here: EUA blog.
2. Disposable surgical N95 masks/respirators that are approved by National Institute for Occupational Safety and Health (NIOSH) to meet N95 standards are 510(k) exempt. However, these masks also have labeling, facility registration, product listing, and U.S. Agency requirements that must be met to sell them as medical devices. It may be possible to convert a non-medical N95 mask to a medical (disposable surgical mask), whether sterile or non-sterile fields are implicated. 
3. Simple NIOSH N95 masks/respirators currently marketed for non-medical, industrial use, which have a NIOSH approval number but have not gone through FDA’s process for converting them to FDA cleared (exempted) surgical masks, would need to have the product labeling reviewed for medical claims, indications for use, warnings, etc., before they can be marketed for use as surgical use masks.
4. Simple industrial, disposable medical or nonmedical masks that are not FDA cleared or NIOSH approved fall into special categories that require a careful review of claims that could cause the mask to be a medical or surgical mask and subject to heightened FDA jurisdiction.

** Note: On March 24, 2020 FDA extended an EUA for non-NIOSH-approved masks permitting importation of devices within this category for medical use. There is a need to comply with certain requirements but relatively speaking they are not too onerous. See this blog for more information:  https://www.fdaimports.com/blog/fda-expands-eu-include-imported-disposable-face-masks/

Senior Regulatory Advisor Tom Knott warns importers, “We expect FDA has set all electronic import screening for these masks at 100% to ensure what is imported actually complies with the FDA requirements.” In fact, we have seen FDA, Customs and Border Patrol, and even ICE/DHS seize or detain these masks.

Our regulatory consultants and affiliated attorneys are available to help firms identify specific mask requirements, clarify their marketing intention, and understand corresponding regulatory requirements. We help companies with 510(k) filings, labeling and claims reviews, facility registration, product listing, U.S. Agency requirements, commercial documentation reviews, all other FDA and FTC regulatory issues, HTS classification questions, and other Customs issues. Contact us today to get started.

This blog is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular FDAImports representative for additional information.