On April 18, 2020, in response to the ongoing COVID-19 pandemic, the United States Food and Drug Administration ("FDA") issued an Emergency Use Authorization ("EUA") for manufacturers and distributors of face masks that will remain in effect for the period of this public health emergency. Specifically, by issuing this EUA, the FDA recognized that there was an urgent need for more flexibility in the rules applicable to the manufacturing of face masks given the insufficient supply for use by health care personnel ("HCP") and the general public. Most importantly, by issuing this EUA, the FDA now allows health care providers to use EUA compliant face masks in their facilities even if the face masks do not constitute surgical masks and do not necessarily provide liquid barrier protection.
This EUA is much needed in that it will allow health care providers to prioritize the use of the scarce FDA-approved face masks for those HCPs in high risk areas for infection and allow face masks that comply with the EUA to be used by HCP in lower risk settings. This EUA also gives face mask manufacturers: (i) confidence to produce face masks without the need to necessarily comply with FDA's standard medical device approvals; and (ii) important guidance regarding product labeling and advertising.
To comply with the April 18, 2020 EUA for face masks, the authorized face masks must meet the following requirements:
- 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
not include any drugs or biologics).
- 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 any surgical setting or where significant
exposure to liquid, bodily or other hazardous fluids, may be
expected, 3) for use in a clinical setting where the infection risk
level through inhalation exposure is high; 4) for use in the
presence of a high intensity heat source or flammable gas, 5) for
antimicrobial or antiviral protection or related uses or uses for
infection prevention or reduction or related uses, or 6) to include
particulate filtration claims.
- 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.
- 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.
- 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 the FDA's webpage "Medical Device Reporting (MDR): How to
Report Medical Device Problems" for reporting requirements
and procedures.
- 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.
- 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.
- 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.
Conditions Related to Advertising and Promotion:
- All printed matter, including advertising and promotional
materials, relating to the use of the authorized face mask shall be
consistent with the labeling elements listed in Section II of this
EUA, as well as the terms set forth in this EUA and the applicable
requirements set forth in the Act and FDA regulations.
- No printed matter, including advertising or promotional
materials, relating to the use of the authorized face mask may
represent or suggest that such product is safe or effective for the
prevention or treatment of patients during the COVID-19
pandemic.
- All advertising and promotional descriptive printed matter relating to the use of the product shall clearly and conspicuously state that:
- The product has not been FDA cleared or approved;
- The product has been authorized by FDA under an EUA for use by
HCP as PPE to help prevent the spread of infection or illness in
healthcare settings and by the general public to help slow the
spread of the virus during the COVID19 pandemic; and
- This product is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices, including alternative products used as medical devices, during the COVID-19 outbreak, under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
Takeaways
The FDA's recent EUA is a useful and "common sense" development, however, healthcare providers and manufacturers alike must take heed to comply with the conditions of the EUA. Importantly, health care providers can conserve FDA-approved masks for sensitive surgical and high risk environments and use the face masks authorized by this EUA as PPE for lower risk environments. Further, manufacturers (including those just recently starting to produce face masks) must understand the above EUA conditions and prepare the appropriate language for the product and accompanying paperwork/packaging. Please also see our alert on tort immunity for manufacturers.
Article originally published on 22 April 2020
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