The Food and Drug Administration has revised its enforcement policies to increase the supply and availability of necessary personal protective equipment (PPE) for the duration of the COVID-19 pandemic.
As a result, FDA will not object to the distribution and use of certain high-demand personal protective products that do not pose an “undue risk” in the absence of FDA-cleared or approved alternatives. To determine whether an undue risk exists, FDA will look to product-specific factors based on, for example, the statements and recommendations made on the product’s labeling or the product’s compliance with specific safety standards. FDA’s revised guidance also provides procedures for decontamination of face masks and respirators and the use of decontaminated products.
FDA’s revised policies specifically address the shortage of N95 masks in two primary ways. In the event that FDA-cleared or National Institute for Occupational Safety and Health (NIOSH)-approved N95 respirators are not available, FDA does not intend to object to the distribution (including importation) and use of respirators identified in the Centers for Disease Control and Prevention (CDC) recommendations. As an alternative, FDA has also issued Emergency Use Authorizations (EUAs) that authorize emergency use of certain foreign-made respirators that have not been approved by NIOSH. Under these EUAs, products that FDA has confirmed meet specific criteria can be eligible for emergency authorization.
Applicability of FDA’s Revised Policies
FDA regulates any product that is manufactured and intended for a medical purpose. such as for the prevention of infectious disease transmission (including uses related to COVID-19). Products manufactured and marketed to the general public for general, non-medical purposes (for example, for use in construction) are not subject to FDA regulations and are not within the scope of the revised policies. To determine whether a product is intended for medical purposes, FDA will consider, among other things, whether the product:
- Is labeled or intended for use by health care professionals
- Is labeled or intended for use in health care facilities or environments
- Includes any drugs, biologics, antimicrobial or antiviral agents
For products that are intended for a medical purpose, FDA’s revised guidance documents lay out the full scope and qualifications necessary for use of these alternative products, as summarized below.
FDA revised its policies in its March 30 guidance document, “Enforcement Policy for Gowns, Other Apparel, and Gloves During the Coronavirus Disease (COVID-19) Public Health Emergency.” This guidance was designed to expand the availability of FDA-regulated personal protective surgical-grade and non-surgical apparel for health care professionals, including gowns (togas), hoods, patient examination gloves, and surgeon’s gloves, during the COVID-19 pandemic.
FDA will not object to the distribution and use of non-FDA-cleared gowns and other protective apparel if these products do not “create an undue risk in light of the public health emergency.” The type of product determines the qualifications (listed in full in the revised guidance document) that can help determine whether a product presents an undue risk as explained in the revised guidance.
- FDA looks to the labeling content (e.g., description of product, notation as not FDA-cleared) and use recommendations (e.g., not for use in a surgical setting) to determine whether non-surgical and minimal-to-low barrier protection products, which do not require premarketing approval, present an undue risk.
- In addition to the above, surgical-grade gowns and apparel (which typically require premarket authorization under Section 510(k) of the Food Drug and Cosmetic Act) are subject to heightened standards relating to, for example, liquid barrier protection, flammability and sterility, to be considered not an undue risk.
FDA further indicated that it will not object to surgeon’s and patient-examination gloves that have not been cleared by FDA as long as they do not create an undue risk in light of the public health emergency.
- Patient examination gloves are not considered an undue risk when, for example, the labeling accurately describes the product (e.g., non-sterile) and contains a statement that the product has not been cleared by FDA.
- Surgeon’s gloves that, among other things, do not meet standard specifications or do not contain labeling that describes sterility status/method are considered an undue risk and would not fall within the scope of FDA’s revised policies.
Face Masks, Face Shields, and Respirators
FDA issued further guidance on PPE in the COVID-19 era titled “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised)” on April 2. This guidance contains policies designed to help expand the availability of general use face masks for the general public and medical-grade respirators for health care professionals during the COVID-19 pandemic. In this guidance, FDA confirms that it will not object to certain face masks, face shields and respirators that do not pose an undue risk.
- Face masks intended for a medical purpose (such as purposes relating to COVID-19) that are not intended to provide liquid barrier protection do not create an undue risk when, for example, the product labeling includes accurate descriptions (e.g., does not describe the product as a surgical mask or filtering facepiece respirator), does not include particulate filtration claims, and does not recommend its use in a surgical setting.
- Face shields intended for a medical purpose do not pose an undue risk where, for example, they include labeling that accurately describes the product as a face shield or include a list of the materials in the face shield (which do not include any drugs or biologics).
- Surgical masks intended to provide a physical barrier to fluids and particulate materials that are tested for flammability and biocompatibility are not an undue risk when, for example, they meet fluid resistance testing standards, meet certain flammability requirements, and include labeling accurately describing the product.
FDA’s revised guidance allows for and provides the proper policies for acceptable decontamination of non-NIOSH-approved disposable filtering facepiece respirators, NIOSH-approved air-purifying respirators, and N95 respirators. Details regarding proper decontamination of PPE are set out in FDA’s revised guidance.
FDA has established certain policies for N95 respirators, which it defines as follows:
A disposable half-mask filtering facepiece respirator (FFR) that covers the user’s airway (nose and mouth) and offers protection from particulate materials at an N95 filtration efficiency level per 42 CFR 84.181. Such an N95 FFR used in a healthcare setting is regulated by FDA under 21 CFR 878.4040 (FDA product code MSH) and is either a class II device that is exempt from premarket notification requirements under section 510(k) of the FD&C Act or is a class II cleared device.
In addition to FDA, the CDC, NIOSH, and Occupational Safety and Health Administration (OSHA) also regulate N95 respirators. Current CDC guidelines reserve N95 masks for healthcare workers and discourage their use by the general public.
CDC Recommendations and FDA Administrative Discretion
As part of its crisis management recommendations, CDC has identified alternative respirators that have been approved under standards used in other countries that can be used when FDA-cleared or NIOSH-approved N95 FFRs are not available. This list of alternatives can be found on the CDC website. In its revised guidance document, FDA stated that it does not intend to object to the distribution (including importation) and use of these respirators identified on the CDC’s website, even if the regulatory requirements listed in the guidance have not been satisfied. Importantly, although FDA will not object to them, these products are not considered to be FDA-cleared or approved.
Emergency Use Authorization
FDA has previously allowed for the emergency authorization of certain NIOSH-approved N95 masks. In response to the continued shortage of N95s, FDA issued a new EUA to Stakeholders for Non-NIOSH-Approved Imported FFRs on March 28. This emergency authorization provides a procedure to obtain emergency authorization for certain non-NIOSH-approved respirators manufactured in Australia, Brazil, Japan, South Korea, Mexico, and Europe. After FDA determines that these products meet certain criteria, these respirators will be authorized for use in health care settings by health care professionals. Authorized respirators that have been decontaminated using an authorized decontamination system likewise remain authorized under this EUA.
FDA issued another new EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China later that week, extending emergency authorization potential to certain Chinese-manufactured respirators that meet specified criteria, including evidence demonstrating authenticity. As with other non-NIOSH-approved products, manufacturers that seek to gain emergency authorization for Chinese-made FFRs must submit to and be verified by FDA prior to importation. More details and information regarding the FDA’s emergency authorization of foreign respirators can be found in FDA’s March 28 and April 3 Letters of Authorization and on FDA’s website.
- FDA’s revised policies and EUAs confirm it is willing to provide regulatory flexibility to address the shortage of PPE in the United States.
- FDA’s policy of allowing PPE that does not present an undue risk is mirrored by its recently revised enforcement policy for clinical electronic thermometers during the COVID-19 outbreak. FDA may continue to expand its policies relating to other diagnostic and prevention devices that do not pose an undue risk going forward.
- Foreign manufacturers of certain N95-alternative products have the choice between enforcement discretion and emergency authorization. The benefits and detriments of each pathway must be adequately weighed and considered prior to distribution of products, as regulatory, labeling, and import requirements differ for each.
- Additional non-FDA requirements, such as those imposed by the CDC, purchasing hospitals, exporting countries, and United States Custom and Border Protection, must also be considered prior to the sale of PPE in the United States.
- Manufacturers or distributors seeking to import PPE are encouraged to seek regulatory counsel to ensure proper compliance with FDA’s policies.