The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:
- 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.
- 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.
- Testing updates:
- To date, there are 150 currently-authorized tests under EUAs; these include 126 molecular tests, 23 antibody tests, and 1 antigen test.