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FDA Expands Face Mask Enforcement Policy to Allow Imports of KN95 Respirators

On April 2, 2020, the Food and Drug Administration (FDA) issued a revised temporary enforcement policy regarding the manufacture and distribution of face masks and filtering facepiece respirators during the COVID-19 public health emergency. The revisions address two key omissions from the initial policy, which was released on March 25, 2020 and which we summarized in a prior blog post. Specifically, the agency has now provided guidance on: (1) the importation of respirators not approved by the National Institute for Occupational Safety and Health (NIOSH) and (2) the manufacture and distribution of face shields. FDA also added a question and answer about respirators manufactured in China to the KN95 air filtering standard (the Chinese equivalent of the U.S. government’s N95 standard) to its FAQ page on the personal protective equipment (PPE) shortage and issued an emergency use authorization (EUA) for non-NIOSH-approved respirators made in China.

Many companies have sought to import respirators from China in an effort to increase supplies in the U.S. and to distribute face shields as protective accessories to face masks and respirators. However, they ran into regulatory obstacles because both products were not included within the scope of FDA’s original enforcement policy. The regulatory difficulties and continued shortage of PPE in the U.S. led these companies to clamor for FDA and the Centers for Disease Control and Prevention (CDC) to open enforcement policies to allow KN95 respirators into the country and to clarify the current enforcement status of face shields. On April 2, the agencies acceded to those requests.

The Addition of KN95 Respirators

FDA’s revised Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency now includes a section on alternative respirators when FDA-cleared or NIOSH-approved respirators are not available. The section references CDC’s Strategies for Optimizing the Supply of N95 Respirators: Crisis/Alternate Strategies website, which previously only listed respirators from Australia, Brazil, Europe, Japan, Korea and Mexico (countries with filtering standards similar to NIOSH standards) as authorized alternatives to N95 respirators. Following FDA’s enforcement policy revisions, this list now includes KN/KP95 and KN/KP100 respirators manufactured in China. Accordingly, such respirator products will be exempt from the following regulatory requirements for the duration of the public health emergency: registration and listing, quality system controls, reports of corrections and removals, and Unique Device Identification. FDA acknowledges in the policy document that it is unable to confirm the authenticity of respirators manufactured to the KN95 standard, so the agency recommends that U.S. importers/distributors be able to demonstrate the authenticity of such respirators through certificates of conformity and test reports (see the EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China), even though such evidence is not required under the revised enforcement policy.

Clarification for Face Shield Products

Face shields intended for medical use occupy a regulatory twilight zone because there is no device regulation or product classification that specifically includes such products, even though they are generally recognized as within the scope of the surgical apparel regulation (21 C.F.R. § 878.4040) as accessories to surgical masks. This ambiguous regulatory classification led many companies to wonder whether FDA’s original enforcement policy on face masks and respirators also covered face shields, as the agency’s omission of face shields from the policy resulted in speculation that regulatory enforcement could still apply to such products. FDA clarified its position on face shields in the April 2 revised policy, expressly stating that face shields not intended for a medical purpose are not medical devices (similar to face masks and N95 respirators not intended for medical purposes) and that shields intended for medical use are exempt from registration and listing, quality system, reports of corrections and removals, and Unique Device Identification requirements. This clarification offers regulatory certainty to various non-regulated entities that are pivoting their existing manufacturing operations to produce face shield products, and, consequently, it was extremely welcome news.

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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.