RE: Update on Enforcement Policy for Face Masks & Respirators During the COVID-19 Public Health Emergency

During the first week of April, the FDA released a guidance document outlining the up-to-date policy regarding face masks and respirators during the Coronavirus (COVID-19) public health emergency. The reason for this guidance is to help expand the availability of general use face masks for the general public and particulate filtering face piece respirators (including N95 respirators) for healthcare professionals during this pandemic. This may help address the public health concerns caused by shortages of such products by taking a risk-based approach and clarifying the policies the FDA intends to apply to masks and respirators, including the products’ associated indications and claims.

Many products are marketed as “face masks” in the United States that offer protection against various potential health hazards. Face masks and respirators are regulated by the FDA when they meet the definition of a device under section 201(h) of the Food, Drug, and Cosmetic Act (FD&C Act). Face masks can fall within this definition when intended for medical purposes, including for use by health care professionals. Face masks, face shields, and filtering facepiece respirators (FFRs) that are marketed to the general public for, general, non-medical purposes, are not regulated by the FDA. These include but are not limited to construction and other industrial applications that are not intended for the use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease. Since they are not regulated products, FDA device marketing authorization is not required. All the other requirements of the FD&C Act do not apply to manufacturers, importers, and distributors of these products.

On April 24, 2020, the FDA re-issued amended guidelines for Emergency Use Authorization for face masks used by members of the general public. The EUA does not require the manufacturer to submit a request to the FDA for emergency use authorization of face masks. To be considered under emergency use authorization, additional conditions must be met including those outlined in the EUA letter in Section IV. Conditions of Authorization which state:

1. Manufacturers and Distributors will make face masks available with labeling that includes a description of the product as a face mask, including a list of the body contacting materials (which does include any drugs or biologics).
2. Manufacturers and Distributors of authorized products shall not label the product: 1) as a surgical mask, to provide liquid barrier protection; 2) for use in a clinical setting where the infection risk level through inhalation exposure is high; 3) for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses; 4) as a respiratory protective device; or 5) for high risk aerosol-generating procedures.
3. Manufacturers must make the required labeling available to each end user or end user facility (each hospital) in hard copy or in an alternative format (e.g., electronic labeling on the manufacturer’s website). Instructions on how to access the labeling if provided in an alternative format must be available to each end user or end user facility.
4. Manufacturers and Distributors will include instructions for recommended cleaning and/or disinfection materials and processes, if applicable, for their authorized product(s). Manufacturers must provide these instructions, if applicable, to each end user or end user facility (e.g., each hospital) in hard copy or in an alternative format (e.g., electronic instructions). Instructions on how to access the labeling if provided in an alternative format must be available to each end user or end user facility.
5. Manufacturers will have a process in place for reporting adverse events of which they become aware to FDA under 21 CFR Part 803. Adverse events of which the manufacturer becomes aware will be reported to FDA. See FDA’s webpage “Medical Device Reporting (MDR): How to Report Medical Device Problems” for reporting requirements and procedures.
6. Manufacturers and distributors will ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon request.
7. Through a process of inventory control, manufacturers and distributors will maintain records of the entities to which they distribute the face masks and the numbers of each such product they distribute.
8. Manufacturers and distributors are authorized to make available additional information relating to the emergency use of the product that is consistent with, and does not exceed, the terms of this letter of authorization.

FDA-regulated face masks and respirators are listed below:

Note: Product code 80Q–KR, Face Mask, (except N95 respirator) for general public/healthcare personnel is also subject to the enforcement policy. Product code 80Q–KU, Non-NIOSH-Approved Disposable FFRs has been created for products listed on the Non-NIOSH-approved EUAs.

If there are any specific questions regarding how your devices can be affected by the FDA EUA or how to deal with the FDA under this Coronavirus situation, please feel free to reach out to mdi for assistance via email at [email protected] RE: COV19.