In addition, FDA described the criteria for obtaining Emergency Use Authorizations (EUAs) for reprocessing single-use or otherwise disposable FFRs and distributing surgical face masks and N95 respirators. The agency also issued a Notice to Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators to allow importation of certain FFRs that are not approved by the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH). As a follow-up to its previous Ventilator Enforcement Policy, FDA provided information on how to obtain an Emergency Use Authorization for ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators.

Enforcement Policy for Face Masks and Respirators

Face Masks and N95 Respirators Not Intended for a Medical Purpose

FDA clarifies that it does not have jurisdiction over face masks 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 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 Intended for a Medical Purpose

FDA is relaxing certain medical device requirements for FDA-regulated face masks 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 or unique device identification 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.

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), and (2) 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 reprocessing single-use or otherwise disposable FFRs, and (2) EUAs for face masks intended for a medical purpose, surgical face masks and N95 respirators. Prospective applicants should review FDA’s suggested information for submission to the CDRH-COVID19-SurgicalMasks@fda.hhs.gov email address carefully.

FDA Notice Regarding Non-NIOSH-Approved Disposable FFRs

FDA also issued its Notice to Manufacturers of Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators. During the COVID-19 public health emergency, the agency is permitting the import of certain FFRs included in Table 1 of the notice, which are not approved by the CDC’s NIOSH. Products that are not listed in the document cannot be imported without first obtaining FDA’s authorization. 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.

Product labeling requirements include: (1) the intended use and other instructions (e.g., fit testing) must be published on the manufacturer’s website in English, and (2) a letter, in English, that can be distributed to each end user facility (e.g., hospitals) that receive the respirator model. The letter must include: (a) the manufacturer name, (b) the model name/number, (c) the intended use and (d) the manufacturer’s webpage.

The manufacturer must also 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.

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.”

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