- 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:
- A new FDA Voices, titled Partnering with the European Union and Global Regulators on COVID-19, explains how the FDA and the European Union, including the latter’s European Medicines Agency, have long leveraged each other’s expertise and experience to promote the safety, effectiveness, and quality of medical products to advance the health of our respective citizens. Now, our work, built together over more than a decade, has paved the way for a multitude of critical collaborations on many scientific and regulatory fronts as part of our response to the global COVID-19 public health crisis.
- FDA’s list of Emergency Use Authorizations (EUAs) for Ventilators and Ventilator Accessories has been updated, adding the AustinP51 (resuscitator) to Appendix B of the ventilator EUA. The AustinP51 is a portable emergency-use resuscitator designed to provide either continuous or intermittent ventilatory support for patients requiring mechanical ventilation through volume control. The AustinP51 emergency-use system (EURS) is for use by professionals qualified and trained in the use of general ventilation equipment, or who are specifically trained on the AustinP51 system. This EURS is intended for use in healthcare settings to treat adults during the COVID-19 pandemic.
- Testing updates:
- To date, there are 150 currently-authorized tests under EUAs; these include 126 molecular tests, 23 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