PPE Update: FDA Revises Policy for Face Masks and Respirators During COVID-19 Pandemic

This May Guidance supersedes the guidance, “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency (Revised),” issued in April 2020. Our prior Alert on FDA’s April Enforcement Policy can be found here.

In addition to its prior enforcement policy issued in April, FDA had also issued three different EUAs: one in April for general face masks (see Arent Fox April Alert on this EUA here) and two for respirators: one in April and another in May focused specifically on respirators manufactured in China (see Arent Fox Alerts here).

The effect of those April and May EUAs on FDA’s previously issued Enforcement Policies for face masks and respirators is the focus of the updated May Guidance. The rest of the May Guidance is, in large part, a reiteration of the previously announced policies. Notably, however, FDA has now announced a more narrow approach for respirators.

General Face Masks

FDA continues to encourage the general public and healthcare professionals to use FDA-cleared face masks as “source control.”[1] However, to help maintain the availability of masks that could offer some benefit, FDA is continuing its April 2 2020 policy regarding general (non-surgical) face masks,[2] recognizing that there is some overlap with the previously issued EUA for these types of masks. In other words, FDA has confirmed that in addition to FDA clearance, there remain two options for the US importation and distribution of general (i.e., non-surgical) face masks: FDA’s May Enforcement Policy and FDA’s April EUA for face masks.

Respirators

In contrast to the status quo approach FDA has announced for general face masks, FDA’s updated May Guidance includes a significant change for respirators intended for medical use. Previously, FDA had provided flexibility regarding the importation and distribution of respirators per its April 2, 2020 Enforcement Policy. That prior policy had provided flexibility regarding the respirators identified in the CDC recommendations and was based on the increasing need for respiratory protection devices for health care professionals.

In its updated May Guidance, however, FDA explains that it has become aware of concerns regarding the performance of certain respirators based on testing conducted by the CDC. FDA has thus determined that greater FDA oversight of respirators that are not FDA-cleared or authorized under an EUA is critical to protecting the public health. Thus, FDA has now announced that it is discontinuing its April 2 Enforcement Policy as applied to respirators. 

Going forward, the importation and distribution of a respirator, including N95s and comparables, will require that the respirator be (1) FDA-cleared through the 510(k) pathway (i.e., receive FDA marketing authorization through FDA’s conventional pathway prior to import), (2) authorized by FDA for emergency use as a respirator, or (3) NIOSH-approved.

If none of these requirements are satisfied, FDA explains in the updated May Guidance that the product could instead be used as a general face mask by the general public and healthcare professionals as “source control” so long as the criteria specified in the EUA for general face masks are satisfied. In that case, the product needs to be labeled accordingly and not used as a respirator.

EUAs for Face Masks Intended for a Medical Purpose, Surgical Masks, and N95 Respirators

For devices that do not fall within the scope of current EUAs, FDA reiterates that it is interested in interacting with manufacturers on additional device-specific EUAs. This may include manufacturers of masks and respirators that are not currently legally marketed in the US, as well as manufacturers who have not previously manufactured masks or respirators but that have capabilities to increase the supply of these devices. The specific information requested by FDA is listed on pp. 10-11 of the May Guidance.

Customs Instructions for Declaring Under an EUA

CBP has not changed its instructions for filing since the April 21, 2020 instructions were issued, as described in our April 23 Alert regarding the importation of face masks generally. However, as we indicated in our previous Alerts, there are different codes that are used when importing under the Enforcement Policy versus importing under an EUA.

[1] As used by FDA, “source control” refers to the use of a face mask or cloth face covering over the mouth and nose to contain that individual’s respiratory secretions to help prevent transmission from infected individuals who may or may not have symptoms of COVID-19.

[2] For surgical masks (non-respirators), FDA’s May Enforcement Policy remains in effect.