This post was updated on April 9, 2020 to include recent developments.
In a series of notices and enforcement-policy statements, the FDA has announced additional efforts to address the critical shortage of face masks, filtering facepiece respirators (FFRs) and ventilators in response to the Coronavirus (COVID-19) public health emergency. This On the Subject reviews these recent policy announcements, to help healthcare providers understand which devices may or may not be used for medical and non-medical purposes, and to clarify certain product labeling requirements, the criteria for requesting emergency use authorizations, and other issues.
On March 25, 2020, the US Food and Drug Administration (FDA) announced additional efforts to address the critical shortage of face masks, filtering facepiece respirators (FFRs) and ventilators in response to the Coronavirus (COVID-19) public health emergency. On April 2, 2020, FDA issued a revised Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised) (“Enforcement Policy”) to increase access to face masks, face shields, surgical masks, and particulate FFRs (including N95 respirators) for healthcare professionals (HCPs). The agency also published an updated FAQ that outlines the agency’s efforts in plain language. FDA will allow individuals and healthcare providers to distribute certain non-FDA-cleared, non-medical face masks and respirators when no FDA-cleared alternatives are available. Perhaps most notably, the agency explicitly states that for the duration of the pandemic, when FDA-cleared or NIOSH-approved N95 respirators are not available, FDA does not intend to object to the importation and use of alternative respirators, including KN95 respirators, if they are on the Centers for Disease Control and Prevention’s (CDC) list of respirator alternatives. FDA is not enforcing premarket clearance requirements and other FDA requirements for FDA-regulated medical face masks, face shields or surgical masks, provided the masks meet certain labeling, technical and safety requirements. The agency also is not enforcing premarket clearance for surgical masks intended to provide liquid and particular barrier protection, provided they meet specified labeling, technical and safety requirements.
Face Masks and N95 Respirators Not Intended for a Medical Purpose
FDA clarifies that it does not have jurisdiction over face masks, face shiels and respirators that are marketed to the general public for general, non-medical purposes (e.g., construction, industrial use) and, as such, the requirements of the Federal Food, Drug, and Cosmetic Act (FDCA) and its implementing regulations do not apply to such masks, shields and respirators. FDA also clarifies that it intends to exercise enforcement discretion to permit “individuals, including healthcare professionals” (but not companies) to distribute and use improvised personal protective equipment (PPE) when no alternatives, such as FDA-cleared masks or respirators, are available.
Face masks and FFRs that are intended for medical purposes are FDA-regulated devices (e.g., those regulated under 21 C.F.R. §§ 878.4040 and 880.6260). FDA will consider factors, such as labeling and promotional claims, intended users and modifications (e.g. anti-microbial agents), to determine whether face masks and FFRs are intended for medical purposes. Factors associated with a medical purpose include:
The product is labeled, marketed or distributed for use by a HCP.
The product is labeled, marketed or distributed for use in a healthcare facility or environment.
The product includes any drugs, biologics, or anti-microbial or anti-viral agents.
Therefore, manufacturers and distributors should pay particular attention to labeling, promotional claims and other representations to avoid confusion between face masks for personal use and FDA-regulated masks for medical settings. FDA clarifies that the policy does not apply to other categories of FDA-regulated face masks, such as those used for oxygen, gas or for humidifier purposes.
Face Masks, Face Shields and Surgical Masks Intended for a Medical Purpose
FDA is allowing the distribution and use of certain medical device requirements for FDA-regulated face masks, with or without a face shield (not including respirators), face shields and surgical masks if manufacturers and distributors implement defined measures to prevent undue risks. FDA will not enforce premarket notification (510k), registration and listing, quality system regulation (QSR) requirements, reports or corrections and removals requirements, or unique device identification (UDI) requirements for medical face masks and surgical face masks if the masks contain appropriate warnings and meet other criteria to prevent undue risks to health. For face shields, FDA clarifies that the face shields are “class I devices exempt from premarket notification requirements under 510(k)” and that FDA will not enforce registration and listing, QSR requirements or UDI requirements for the shields.
The enforcement policy applies to (1) face masks intended for a medical purpose (whether used by the general public or health care professionals) that are not intended to provide liquid barrier protection (not including respirators), (2) face shields intended for a medical purposes, and (3) surgical masks intended to provide a liquid and particulate materials barrier protection provided the masks do not provide undue risk as defined by the agency (see below):
Emergency Use Authorizations (EUAs) for Masks and Respirators
FDA also sets forth its intended approach to EUAs for masks and respirators, specifically (1) EUAs for decontaminating otherwise disposable face masks, and (2) EUAs for face masks intended for a medical purpose, surgical face masks and N95 respirators. Prospective applicants should carefully review FDA’s suggested information for submission to the CDRH-COVID19-SurgicalMasks@fda.hhs.gov email address.
FDA EUA Notice Regarding Non-NIOSH-Approved Disposable FFRs
The Non-NIOSH-Approved FFRs EUA only applies to those authorized respirators listed in Exhibit 1 of the EUA or authorized respirators in Exhibit 1 that have been decontaminated. In order to be added to Exhibit 1, the respirators must meet one of the two criteria outlined in the Non-NIOSH-Approved FFRs EUA:
Criteria 1: Disposable FFRs that have been designed, evaluated and validated to meet a given performance standard and have corresponding acceptable product classifications, as follows:
(See EUA, Table 1)
Criteria 2: Disposable FFRs which have a marketing authorization in one of the following regulatory jurisdictions:
European CE Mark
Australian Register of Therapeutic Goods (ARTG) Certificate of Inclusion
Health Canada Licence
Japan Pharmaceuticals and Medical Device (PMDA)/Ministry of Health Labour and Welfare (MHLW)
If a manufacturer or importer wants to add an authorized respirator to Exhibit 1, the entity must send a request to FDA by email to CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov of their intent to import non-NIOSH-approved disposable respirators that are eligible for authorization under either (or both) of the two criteria described in the EUA. Manufacturers or importers of non-NIOSH-approved FFRs should carefully review the EUA for the information required for submission via email to the FDA. Notably, the EUA did not include FFRs manufactured in China.
FDA also provides a mechanism to ask FDA to include other non-NIOSH-approved masks by emailing CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov with the following information: manufacturer, model number(s), marketing authorizations (if any), applicable performance standards, estimated number for import, certificate(s) of conformity (if applicable) and a copy of product labeling.
Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China
In response to a continued shortage of respirators, on April 3, 2020, FDA issued a new EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China. Under this Non-NIOSH-Approved Chinese FFRs EUA, additional respirators, including KN95 respirators, are eligible for authorization if certain criteria are met. The Non-NIOSH-Approved Chinese FFRs EUA only applies to those authorized respirators listed in Appendix A of the EUA or authorized respirators in Appendix A that have been decontaminated. In order to be added to Appendix A, the respirator must meet one of the following criteria outlined in the Non-NIOSH-Approved Chinese FFRs EUA:
Manufactured by an entity that holds one or more NIOSH approvals for other models of FFRs produced in accordance with the applicable standards of authorization in other countries that can be verified by FDA
Has a regulatory authorization under a jurisdiction other than China that can be authenticated and verified by FDA
Demonstrates acceptable performance to applicable testing standards as documented by test reports from a recognized independent test laboratory that can be verified by FDA
If a manufacturer or importer would like to add respirators to Appendix A as an authorized respirator under this EUA, they must send a request to FDA with the subject line “FFRS Made in China” to CDRH-NonDiagnosticEUATemplates@fda.hhs.gov. The request must contain the information outlined in the EUA, so interested entities should carefully review the EUA to determine what information must be submitted to FDA.
General EUA Information
For both EUAs, manufacturers must have a process in place for handling adverse event reports and sending these reports to FDA as well as for maintaining records that can be held for inspection by FDA upon request. The FDA notice also includes specific requirements for importers who repackage or relabel the product. Finally, labeling should be consistent with CDC recommendations for use during the COVID-19 public health emergency and not represent or suggest the product is safe or effective for the prevention of COVID-19.
Alternatives When FDA-Cleared or NIOSH-Approved N95 Respirators Are Not Available
Under the revised Enforcement Policy, when FDA-cleared or NIOSH-approved N95 respirators are not available, FDA is allowing the distribution (including importation) and use of respirators identified in the CDC recommendations (e.g., KN95 respirators) without compliance with the following FDA requirements: premarket notification (510k), registration and listing, QSR, reports or corrections and removals, or UDI. Notably, the respirators allowed under the revised Enforcement Policy now include KN95 and KP95 respirators from China. For a full list of alternative acceptable products, see CDC’s Strategies for optimizing the Supply of N95 Respirators; Crisis//Alternate Strategies. FDA encourages importers to take appropriate steps to confirm the authenticity of their imported products.
Steps for Manufacturers or Importers of Respirators
Based on our review of the revised Enforcement Policy and EUAs, we suggest the following steps for manufacturers or importers seeking to import respirators into the United States.
First, the interested entity should determine if the respirator is covered under the Enforcement Policy by checking if it is identified by product classification in CDC’s recommendations for alternatives to NIOSH-approved respirators. If the respirator is included in the CDC’s recommendations, the entity can import the product to the United States without further action during the COVID-19 public health emergency.
If the entity is an importer and the respirator is not included in the CDC’s recommendations, the importer should then review the appropriate EUA to determine whether the manufacturer and respirator are listed in the EUA. If they are listed, the importer will be able to import the respirators into the United States.
If the respirators are not listed in the EUAs, manufacturers or importers interested in importing the products to the United States should review the criteria in the appropriate EUA to determine if the respirator would be eligible for authorization under the EUA. If the respirators meet the criteria in the applicable EUA, the entity may then submit a request to FDA with the required information to have the products authorized under the EUA. Once FDA reviews the information and authorizes the respirators under the EUA, the entity can import them to the United States.
Emergency Use Authorization for Ventilators
FDA also announced its EUA for ventilators, “authorizing the emergency use of ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as ‘ventilators’).” The EUA is limited to specifically listed authorized ventilators, ventilator tubing connectors, and ventilator accessories listed in Appendix B of the EUA. The current version of the EUA does not contain Appendix B. FDA is aware of the omission and we expect that the agency will update the guidance soon.
The only ventilator products that are currently eligible under the EUA are (1) those that are not currently marketed in the United States, or (2) those that are currently marketed in the United States but to whom a modification would normally trigger the requirement for a new 510(k) premarket notification. (In a separate communication, FDA noted that they remain open to the possibility of approving an EUA for companies that do not currently manufacture any medical devices, but such products would not appear eligible under the current version of the EUA).
Manufacturers may ask FDA to add additional ventilators, ventilator tubing connectors or ventilator accessories to the EUA by submitting information to CDRH-COVID19-Ventilators@fda.hhs.gov for FDA’s assessment. Submissions should include the following information:
Contact information, general information about the device, and marketing authorizations in other countries, including country of origin (if any)
A copy of product labeling
Whether the device currently has a marketing authorization in another regulatory jurisdiction
Whether the device has been designed, evaluated and validated in accordance with FDA-recognized standards for such devices
Whether the device is manufactured in compliance with FDA’s Quality System Regulation (QSR), or ISO 13485, or other internationally recognized quality management systems
Whether the device is designed with a US-compatible power supply (i.e., voltage, frequency, plug type standards) or is accompanied with an appropriate adapter
Information sufficient to demonstrate that the device meets the criteria for safety performance and labeling set forth by FDA.
Additionally, ventilators must be accompanied by a fact sheet for HCPs and a fact sheet for patients, respectively, regarding the emergency use of the ventilators during the COVID-19 pandemic, collectively known as “authorized labeling.” Manufacturers must also have a process in place for collecting and reporting adverse events to FDA under the reporting requirements in 21 CFR Part 803, and they must maintain records associated with the EUA (e.g., inventory control, distribution records) which they must make available to FDA for inspection upon request. The requirements to provide authorized labeling and maintain records also apply to authorized distributors of the devices.
Any advertising for ventilators, ventilator tubing connectors, or ventilator accessories must clearly and conspicuously state each of the following:
“This ventilator, ventilator tubing connector, or ventilator accessory (as applicable) has not been FDA cleared or approved”
“This ventilator, ventilator tubing connector, or ventilator accessory (as applicable) has been authorized by FDA under an EUA”
“This ventilator, ventilator tubing connector, or ventilator accessory (as applicable) is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of ventilators, ventilator tubing connectors, and ventilator accessories under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.”