Excerpt of U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 22, 2021 | site |



(Excerpt of information contained in U.S. Food and Drug Administration [FDA] press release dated: January 22, 2021)
  • The FDA is reissuing the Emergency Use Authorizations (EUAs) for decontamination systems that are authorized to decontaminate compatible N95 respirators for use by healthcare personnel (HCP) to prevent exposure to pathogenic biological airborne particulates when there is an insufficient supply of new respirators resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. Among other things, the reissued EUAs for certain decontamination systems are now only authorized to decontaminate each compatible N95 respirator a maximum of four or fewer times.

    Based on the FDA’s review of real-world use of these systems and evidence from adverse events and scientific literature, including studies regarding N95 respirator failures from simulated and real-world use, the FDA has determined that it is appropriate to protect the public health or safety to revise certain decontamination system EUAs to limit the number of decontamination cycles and respirator reuses permitted under each authorization.
  • Today, the FDA also added two new devices to the device discontinuance list on our web page that lists medical device shortages during the COVID-19 public health emergency. There are no updates to the device shortage list at this time. The FDA will continue to update the device shortage and device discontinuance lists as the COVID-19 public health emergency evolves. Specifically, the FDA added the following devices to the device discontinuance list:
    • 3M Company's 3M Triple Layer Molded Face Mask (2042F) and 3M Triple Layer Molded Face Mask, Petite (2042FP)
    • BioFire Diagnostics, LLC's FilmArray Instrument (FLM1-ASY-0001)
  • Testing updates:
    • As of today, 319 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 237 molecular tests and sample collection devices, 69 antibody tests, and 13 antigen tests. There are 33 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.