- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA issued an Emergency Use Authorization for the Stryker Sustainability Solutions (SSS) VHP N95 Respirator Decontamination System (RDS). This product uses vapor hydrogen peroxide (VHP) to decontaminate compatible N95 respirators that are, or potentially are, contaminated with SARS-CoV-2 or other pathogenic microorganisms for multiple-user reuse by healthcare personnel to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of face-filtering respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. N95 respirators containing cellulose-based materials are incompatible with the SSS VHP N95 RDS. This system is operated by employees of Stryker Sustainability Solutions, whose facilities are designed to allow adequate space for receiving respirators for decontamination, visually inspecting respirators for gross contamination or damage, exposing respirators to VHP, and packaging or labeling them for return to the sender so as to minimize contamination and ensure orderly handling procedures. With respirators limited to a maximum of three decontaminations, each is permanently marked to indicate the number of decontamination cycles it has undergone.
- Yesterday, the FDA further supported its effort to evaluate diagnostic tests of COVID-19 by providing a SARS-CoV-2 reference panel. This panel is an independent performance validation step for diagnostic tests of SARS-CoV-2 infection that are being used for clinical, not research, purposes. The FDA panel is available to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process or whose tests have been issued an EUA. The FDA will provide the reference panel to developers at the appropriate stage in the process. There is no need for these test developers to take additional action in order to receive the reference panel.
- Testing updates:
- During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted, or said they will be submitting, EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
- To date, the FDA has authorized 113 tests under EUAs, which include 100 molecular tests, 12 antibody tests, and 1 antigen test.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Lee Herring