UPDATE 05.05.20
Emergency Use Authorization for Respirators
FDA granted Emergency Use Authorization (EUA) for certain filtering facepiece respirators (“respirators”) and other personal protective equipment during the COVID-19 public health emergency. Under an EUA, FDA authorizes the distribution and use of respirators that do not comply with FDA’s registration, listing, and 510(k) premarket notification requirements.
Respirators covered by an EUA are listed on FDA’s website at:
These EUAs only apply to those respirators intended to be used by healthcare professionals.
Temporary Enforcement Policies for Surgical and Medical Non -Surgical Masks
FDA has also established temporary enforcement policies for medical non-surgical masks and surgical masks during the COVID-19 public health emergency. Surgical masks are masks used in healthcare facilities and are intended to provide protection from bodily fluids (i.e. liquid barrier protection). Masks used in healthcare facilities but which do NOT provide this liquid barrier protection are non-surgical medical masks.
FDA does not intend to object to the distribution and use of surgical and medical non-surgical masks that do not comply with registration, listing, 510(k) and certain other regulatory requirements if FDA believes use of the masks would not create any “undue risks”. For example, FDA may not object to the distribution of surgical masks if the company provides evidence showing that the products meet the appropriate performance standards (e.g. protection from blood), meet flammability requirements, and have labeling that accurately describes the products.
Protective face masks may or may not be regulated by the FDA depending on how they are intended to be used. If FDA regulates the mask, they are subject to FDA’s medical device requirements.
Devices that are intended to prevent disease meet FDA’s definition of a “medical device”. So if the mask is intended to protect its wearer from airborne pathogens such as the COVID-19 virus, then FDA regulates the product as a medical device. Medical devices must meet the following requirements:
Establishment Registration
The manufacturer, initial importer, contract sterilizer, specification developer, re-labeler, and any other establishment involved in the processing, development, or distribution of the masks must be registered with the FDA as a medical device establishment. Some of these establishments are required to pay FDA an annual user fee which is expected to increase each fiscal year.
Medical device establishment registrations must be renewed annually, and establishments that are required to pay the user fee must pay the fee each year.
US Agent for Foreign Establishments
Registered facilities in foreign countries must have a US agent. The US agent must be located in the US and receive communications from FDA and assist FDA with scheduling any inspections of the foreign facility.
Official Correspondent
The owner or operator of a medical device establishment (domestic or foreign) must designate an official correspondent for the company. For foreign companies, the official correspondent may or may not be the same entity as the US agent. FDA may contact the official correspondent for issues regarding the annual registration of the establishment and the listing of its devices. The official correspondent receives communications from FDA and must provide FDA the names of all the company’s officers, directors, and partners if FDA requests that information.
Device Listing
The manufacturer, foreign exporter, and certain other establishments are required to list their medical devices with FDA. Each listed device is assigned a device listing number. For importing a medical mask, the Customs filer/broker must declare the manufacturer’s device listing number to FDA for every shipment.
Premarket Notification (“510k”)
Surgical masks are designed to protect the wearer from bodily fluids (liquid barrier protection) and are class II medical devices requiring premarket notification to FDA, known as a “510(k)”. The 510k must show that the mask is substantially equivalent to a surgical mask already on the market in terms of safety and efficacy. Note that medical procedural masks that are intended for use in healthcare facilities but that are not intended for liquid barrier protection or use in areas where risk of infection is high, are not surgical masks and are class I medical devices that do not require 510(k) premarket notification.
Label Compliance
The product label must comply with all FDA medical device labeling requirements such as having a properly declared statement of identity, net quantity of contents, intended use and indications for use, directions, contraindications, warnings, precautions, business name and address (manufacturer, distributor, or packer), country of origin, date of issuance, and Unique Device Identification (UDI).
Good Manufacturing Practices
The manufacturer must comply with FDA’s medical device Quality System (QS) regulation and Good Manufacturing Practices (GMPs). The GMPs include requirements for the methods, facilities, and controls used in the designing, manufacturing, labeling, packing, storing, installing, and servicing of the mask products.
N95 Respirators
N95 respirators are facial protective devices used to protect the wearer from harmful airborne particles. They are regulated by the National Institute for Occupational Safety and Health (NIOSH) which is part of the Centers for Disease Control and Prevention (CDC). These respirators require NIOSH certification.
N95 respirators intended for use in industrial settings such as construction sites or factories to protect workers from dust and debris are not regulated by FDA. However, N95 respirators that are intended for medical use (e.g. use in healthcare facilities) are regulated by FDA as well as NIOSH. These N95 respirators are class II medical devices but are exempt from the 510(k) premarket notification if the respirator:
- is not intended to prevent specific diseases or infections
- is not labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity.
- does not contain coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms).
Masks Not Intended for Medical Purposes
If the masks are not intended for medical use e.g. the masks are for general purpose or industrial use, then the products are not regulated by FDA. Such masks should not be labeled with any claims suggesting the masks offer protection against disease. US Customs recently advised import filers to disclaim or not transmit the entry data to FDA when filing the entries for those products.