The Food and Drug Administration granted an Emergency Use Authorization (EAU) for a Florida-based company’s product to be used in addressing the ventilator shortage problem in America. The device, a Bi-level PAP (Bilevel Positive Airway Pressure) ventilator, is designed for the treatment of adult Obstructive Sleep Apnea (OSA) for COVID-19 patients.
Shook attorney Sonali Gunawardhana, a former FDA attorney, was able to assist 3B Medical in gaining the necessary authorization for the product to be used in the United States. Previously, it was only authorized for distribution in Europe under a CE mark.
“I’m really pleased the FDA reviewed and agreed upon the merits to use the product,” said Gunawardhana, who practices from Shook’s Washington, D.C. office. “It’s deeply rewarding to see a client with innovative thinking gain approval to help with an issue that has become all too real for Americans.”
3B Medical produces the Luna G3 BPAP 25A- LG3700, in China. The reimagined product will soon be delivered to the U.S. for use in hospitals. Two thousand of the devices are expected to arrive in the near future and ongoing, 3B Medical, will be able to produce 10, 000 a month.
Gunawardhana advises medical device manufacturers on bringing products to market in the changing FDA regulatory environment. She spent a decade at the FDA before moving to Shook to help bolster the firm’s regulatory depth.