Mar 30, 2021

On March 24, 2021, the US Food and Drug Administration (FDA) reissued one of its Emergency Use Authorizations (EUAs) covering imported respirators that have not been approved by the National Institute for Occupational Safety and Health (NIOSH). This is one of numerous EUAs that were issued during the early months of the COVID-19 public health crisis in an attempt to ensure the availability of critical healthcare products. The “Umbrella EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs)” continues to be valid, but the FDA is now restricting its use to previously authorized respirators.

EUA on imported, non-NIOSH-approved disposable FFRs limited to previously approved products

This EUA was initially issued on March 24, 2020, with revisions being made on March 28 and June 6 of that year to adjust its scope. It authorized the use by healthcare professionals in healthcare settings of imported FFRs used according to CDC recommendations when necessitated by FFR shortages. A list of devices authorized under this EUA (“Exhibit 1”) was drawn up, and any product that met one of three eligibility criteria provided under the EUA could be added to Exhibit 1 upon FDA review. (This EUA does not apply to FFRs imported from China, which are covered by the “Umbrella EUA for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (FFRs) Manufactured in China.” This separate EUA was issued on April 3, 2020 and reissued on October 15 of the same year.)

In a letter to stakeholders accompanying the reissued EUA, the FDA explained that that the eligibility criteria have now been removed, and no additional FFRs will be added to Exhibit 1 from this point forward. Companies that have already requested the inclusion of their products in Exhibit 1 and are awaiting an FDA decision are advised in an updated FAQ page on non-NIOSH-approved respirators that their requests will not be approved and that they should pursue other options.

Lack of demand from healthcare organizations cited in FDA decision

The FDA cites discussions with healthcare organizations about the use of non-NIOSH-approved FFRs imported from countries other than China as the background for its decision to remove the eligibility criteria. Respondents are said to have indicated that these products are not in high demand and that their members preferred to use NIOSH-approved respirators.

No further information has been provided about the possibility of the FDA similarly curtailing the authorization of disposable FFRs imported from China or other forms of personal protective equipment (PPE). Stakeholders with questions not addressed in the letter or FAQ page mentioned above are encouraged to contact the FDA's Center for Devices and Radiological Health (CDRH) at CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.

More US FDA resources for medical devices and IVDs during the COVID-19 pandemic:

Author

  • Timothy Herr

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