In recent days, the United States has registered record data on Coronavirus infections. Over 500 thousand cases in one week. The total budget of the Country has risen to 9 million cases. For this reason, FDA (U.S. Food and Drug Administration) is doing its utmost to implement actions able to fight the pandemic.
Vaccines, tests and Medical Devices
Together with the advisory Commettee on vaccines and related products (VRBPAC Vaccines and Related Biological Products Advisory Committee), which is composed of independent experts and scientists, FDA is carrying out checking and monitoring actions to promote timely development and to authorise the production of safe and effective COVID-19 vaccines.
To date, however, no vaccines has been approved by the FDA.
At the same time, through testing, infections from COVID-19 continue to be tracked. At the moment, according to the Emergency Use Authorization (EUA), FDA authorised 287 tests that include 223 molecular tests, 57 antibody tests and 7 antigen tests.
As for Medical Devices, FDA constantly monitors the product supply chain, paying particular attention to those essential which are most required to cope with this health emergency, such as Personal Protective Equipment (PPE) like masks, respirators, surgical gowns and gloves.
FDA guidelines to cope with the pandemic
On the FDA website it is possible to consult all guidelines and any updates related to the pandemic. (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products). In particular, on October 28, FDA updated the guide “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (Revised)”, concerning the use of non-invasive remote monitoring devices to support patient monitoring during the COVID-19 health emergency.
Having regard to the increasing spread of Coronavirus, FDA will continue to monitor the situation in order to implement promptly actions which can combat the pandemic and to assess the publication and update of the COVID-19 guidelines.