- For Instant Launch:
The U.S. Meals and Drug Administration as we speak introduced the next actions taken in its ongoing response effort to the COVID-19 pandemic:
- Immediately, the FDA issued a Letter to Well being Care Suppliers on Utilizing Ventilator Splitters In the course of the COVID-19 Pandemic to supply up-to-date data regarding multiplexing ventilator tubing connectors, often known as ventilator splitters, in conditions through which no options for invasive ventilatory help can be found. The Letter to Well being Care Suppliers additionally contains essential details about ventilator splitters, together with descriptions of options which will scale back sure dangers related to the usage of ventilator splitters, concerns for well being care suppliers and services when utilizing ventilator splitters, and directions for reporting issues with a tool to the FDA.
- Testing updates:
- As of as we speak, 323 exams and pattern assortment gadgets are approved by the FDA underneath emergency use authorizations (EUAs). These embody 240 molecular exams and pattern assortment gadgets, 69 antibody exams and 14 antigen exams. There are 35 molecular authorizations that can be utilized with home-collected samples. There may be one molecular prescription at-home take a look at, one antigen prescription at-home take a look at and one over-the-counter (OTC) at-home antigen take a look at.
The FDA, an company inside the U.S. Division of Well being and Human Companies, protects the general public well being by assuring the security, effectiveness, and safety of human and veterinary medication, vaccines and different organic merchandise for human use, and medical gadgets. The company is also accountable for the security and safety of our nation’s meals provide, cosmetics, dietary dietary supplements, merchandise that give off digital radiation, and for regulating tobacco merchandise.
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