- 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 (EUA) to NovaSterilis, Inc. for its Nova2200, which uses the NovaClean decontamination process. Nova2200 can be used to decontaminate compatible N95 respirators for single-user reuse by healthcare personnel (HCP) to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of face-filtering respirators (FFRs) during the COVID-19 pandemic.
- The FDA issued a letter to health care providers (HCP) and health care facilities alerting them of the potential that passive protective barriers (those without negative pressure) pose an increased health risk to patients and HCPs when treating patients who are known or suspected to have Coronavirus Disease 2019 (COVID-19).
- Testing updates:
- To date, the FDA has currently authorized 218 tests under EUAs; these include 176 molecular tests, 39 antibody tests, and 3 antigen tests.
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.
- Courtney Rhodes