The ID Pipeline: FDA Activity From the Week of April 5, 2020

Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of April 5, 2020.

FDA Issues Emergency Use Authorization for Decontamination of N95 Respirators

The FDA has issued an emergency use authorization that will support the decontamination of 750,000 N95 respirators per day in the United States. The authorization will permit the decontamination of N95 or N95-equivalent respirators for health care workers in the hospital setting to reuse.

“Authorizing this sterilization system will make it easier for hospitals to ensure that heroic healthcare workers on the frontlines have the protection they need,” said HHS Secretary Alex Azar in the announcement.

The authorization was granted to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems. The systems use STERIS N95 Decontamination Cycle (non-lumen cycle) which features the use of vaporized hydrogen peroxide.

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FDA Authorizes Blood Purification Device for COVID-19

The FDA has granted emergency use authorization for a blood purification system to treat adult patients with coronavirus disease 2019 (COVID-19). The system can be used among patients 18 years or older who have been admitted to the intensive care unit and are currently experiencing or will experience respiratory failure.

The authorization was granted to the Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices by Terumo BCT Inc. and Marker Therapeutics AG.

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FDA Issues Emergency Use Authorization for SARS-CoV-2 Serological Test

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization to a serological test which detects antibodies against SARS-CoV-2. The authorization was given to Cellex Inc..

While the precise length of time for which individuals with COVID-19 produce antibodies is still unknown, it is believed the test can diagnose acute or recent SARS-CoV-2 infection.

The test is a lateral flow immunoassay providing the qualitative detection of IgM and IgG antibodies against SARSCoV-2 in serum, plasma, or venipuncture whole blood. Results are obtained in 15 to 20 minutes.

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