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FDA Creates Regulatory Exemptions for Face Masks and Respirators in Response to the Spread of COVID-19 and Critical PPE Shortages

On March 25, 2020, the Food and Drug Administration (FDA) issued a temporary policy relating to enforcement of regulatory requirements for face masks and respirators during the COVID-19 crisis. Since the public health emergency began, the United States has experienced a shortage of masks, respirators, and other personal protective equipment (PPE) which are critically needed for health care workers caring for COVID-19 patients in all states. FDA previously created emergency use authorizations (EUAs) for NIOSH-approved disposable respirators for use in health care settings and imported non-NIOSH-approved disposable respirators, but the temporary enforcement policy represents an attempt to open the manufacturing, importation, and distribution flood gates to make more masks and respirators available as quickly as possible.

The policy is limited to face mask and respirator products classified under 21 C.F.R. §§ 878.4040, 880.6260 (product codes FXX, OXZ, OUK, MSH, ONT, ORW, and NZJ), and FDA divides these products into three main categories: (1) face masks and N95 respirators not intended for a medical purpose; (2) face masks intended for a medical purpose but not to provide liquid barrier protection; and (3) surgical masks intended to provide liquid barrier protection. Each category is subject to different regulatory exemptions, but importantly:

  • When face masks or N95 respirators are marketed to the general public for general, non-medical purposes, they are exempt from marketing authorization requirements, and the manufacturers, importers, and distributors are exempt from all Federal Food, Drug, and Cosmetic Act requirements
  • Face masks intended for a medical purpose but not to provide liquid barrier protection are exempt from the following requirements:
    • Premarket notification (submission of a 510(k))
    • Registration and listing
    • Quality system regulation
    • Reports of corrections and removals
    • Unique device identification
  • Surgical masks intended to provide liquid barrier protection are exempt from premarket notification requirements only.

Each of the exemptions above is contingent on the product or labeling not creating any undue risk for users, and the policy provides specific guidance for reducing undue risks. Manufacturers seeking to take advantage of the temporary policy to introduce PPE into the market should take care to ensure that all labeling complies with the policy requirements.

FDA also describes a need for manufacturers that can reprocess N95 respirators and other filtering facepiece respirators so that such PPE may be safely reused. For reprocessors that can meet the informational requirements explained in the policy, the agency will consider awarding an EUA for the reprocessed respirators.

The policy also states that manufacturers of any face masks or respirators that do not meet the criteria of the agency’s previous EUAs for disposable respirators should contact FDA with relevant information about such products so that the agency can consider issuing additional EUAs for them.

Finally, FDA explicitly states in the policy that it does not intend to object to the manufacture, distribution, and use of improvised masks or other PPE when FDA-cleared masks and respirators are unavailable.

FDA continues to create substantial regulatory accommodations for certain types of medical product in the interest of quickly making as many such products as possible available for health care workers and the general public to counteract the spread and effects of the novel coronavirus, and the enforcement policy for face masks and respirators is no exception. For example, it also issued guidelines on March 24 in conjunction with Customs and Border Protection aimed at facilitating the importation process for PPE products. We will continue to monitor the federal response to coronavirus from a variety of legal and regulatory angles.

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Benjamin advises pharmaceutical, medical device and biotech companies on the FDA regulatory process to identify the correct regulatory pathway, assisting with FDA communications and strategy.