FDA Updates Enforcement Policy for Masks and Respirators

In September 2021, the U.S. Food and Drug Administration (FDA) updated its enforcement policy for masks and respirators during the COVID-19 pandemic that was originally issued in April 2020. The initial policy provided flexibility in regards to certain regulatory requirements for these products under certain circumstances by including a blanket Emergency Use Authorization (EUA) for masks that comply with the policy’s conditions. Among other requirements, the policy waived the requirement to submit pre-market notification for products that met the conditions, significantly diminishing the regulatory barrier to market entry. FDA enacted the policy hoping to increase the supply of masks in the U.S. to combat the nationwide shortage in the early stages of the pandemic.

Read on to learn about recent changes in FDA’s enforcement policy on masks and respirators.

Initial Policy Implemented in 2020

In the initial enforcement policy, FDA only extended the EUA option to eligible companies whose products, among other requirements, did not pose an “undue risk” to the population. According to FDA, one of several examples of avoiding undue risk is that the mask does not have certain labeling claims that might be misleading. For example, the label should not claim that the product has “antimicrobial or antiviral protection, infection prevention or reduction, or related uses”. Masks that make such claims require FDA clearance and are not eligible for blanket EUA status, but can submit an EUA to FDA for those claims.

FDA also extended EUAs to certain respirators so that health care facilities would have enough during the crisis. FDA recommends that health care personnel only use respirators that are FDA-cleared or that are National Institute for Occupational Safety and Health (NIOSH)-approved N95 respirators. However, NIOSH-approved respirators were in short supply at the start of the pandemic. In response, FDA extended EUAs to certain non-NIOSH-approved respirators that were either a class II device exempt from 510(k) premarket notification or a class II device that was 510(k)-cleared.

Changes to the Enforcement Policy

In June 2021, FDA announced a revocation of the EUA for non-NIOSH-approved disposable respirators in health care settings, citing an increased supply of NIOSH-approved N95 respirators. FDA removed references to use of alternatives when FDA-cleared or NIOSH-approved N95 respirators are not available.

The revision also alters the policy to state that FDA doesn’t intend on objecting to the distribution of stockpiled non-NIOSH-approved respirators for the purposes of source control in the public setting as long as these respirators do not pose an undue risk. The revision states that such a product must include labeling that accurately describes it as a face mask (as opposed to a barrier face covering, surgical mask, or respirator).

The policy now includes barrier face coverings used for medical purposes but not for respiratory or fluid barrier protection. The product must include labeling that accurately describes the product as a barrier face covering (as opposed to a face mask, surgical mask, or respirator). The guidance says that these are subject to ASTM’s standards for submicron particulate filtration efficiency, airflow resistance, and leakage assessment. FDA’s authorization of barrier face coverings is similar to that of masks, and face coverings should also not be used as a substitute for NIOSH-approved N95 respirators in a healthcare setting.

Recent FDA Enforcement Actions

Though FDA’s enforcement policy is intended to reduce regulatory barriers to market entry, during the COVID-19 Public Health Emergency, FDA is taking enforcement actions against companies distributing masks that violate the COVID-19 enforcement policies. In a Warning Letter to Invisi Smart Technologies UK LTD, FDA states that the company’s website includes statements that their masks are intended for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. As previously mentioned, because the masks’ claims implied antimicrobial or antiviral protection, infection prevention or reduction, or related uses, they were not eligible for EUA status, and FDA had not authorized them to be on the market.

In a letter to the healthcare industry, FDA urged healthcare workers to discontinue use of a N95 respirators manufactured by Shanghai Dasheng, as the respirators had lost NIOSH-approval. FDA writes that the respirators are no longer authorized for emergency use because “the company did not implement, maintain, and control a quality management system”. These oversights resulted in the loss of NIOSH-approval.

FDA followed the June 2021 announcement of the EUA revocation for non-NIOSH-approved respirators with a more extensive notice listing all models that were authorized at the time of the revocation. The notice also listed models that had previously been revoked in 2020 after FDA updated the EUA’s eligibility criteria.

Preparing Your Masks or Respirators for the U.S. Market

If you are ready to market your products to U.S. consumers, Registrar Corp’s Regulatory Specialists can help you understand how to comply with FDA’s updated requirements. We can also help you register with FDA as your Official Correspondent or act as your U.S. Agent if you are located outside of the United States. For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livechat.

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For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day: www.registrarcorp.com/livechat.


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