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US FDA calls on device, apparel makers to bolster supplies amid coronavirus

The U.S. Food and Drug Administration said it has reached out to more than 1,000 device manufacturing sites around the world as well as clothing designers and other businesses to bolster the supplies of equipment essential to fighting the coronavirus pandemic.

The agency is focusing on products that are in high demand including ventilators and personal protective equipment, such as face masks and gloves, and devices that face potential supply disruptions.

"The need for ventilators, ventilator accessories, and other respiratory devices may outpace the supply available to healthcare facilities," Commissioner Stephen Hahn said in a March 28 statement posted on the agency's website. "We have issued an immediately in effect guidance outlining a policy intended to help increase availability of ventilators and their accessories as well as other respiratory devices."

The agency on March 23 made it easier for manufacturers to produce respiratory devices such as ventilators to accommodate demands associated with the coronavirus pandemic. Some companies that make ventilators have already ramped up production.

"We are continuing to work on strategies to increase the availability of these devices," Hahn said.

President Donald Trump has ordered General Motors Co. to make ventilators to ease the supply shortage for U.S. hospitals. New York Gov. Andrew Cuomo said March 24 that his state needed at least another 30,000 ventilators to support coronavirus patients.

Meanwhile, the U.S. Department of Defense agreed to buy 8,000 ventilators from four companies Zoll Medical Corp., Combat Medical Systems LLC, Vyaire Medical Inc. and Hamilton Medical Inc. — for $84.4 million after altering a current contract, Bloomberg News reported. About 1,400 will be delivered by early May.

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The FDA is in talks with textile companies and clothing designers on how they can use their manufacturing facilities to produce face masks. The benefits of using masks made this way outweigh the risks, Hahn said.

"We are providing maximum regulatory flexibility where we can," Hahn wrote.

Chanel SA said March 29 that it will produce face masks for the French market, Reuters reported.

Hahn's agency is also working to ease the importation of protective equipment into the U.S.

To preserve the supply of certain medicines, such as chloroquine and hydroxychlorquine, some retail pharmacies have taken steps to curb overprescribing and overdispensing, Hahn said.

The regulator is not stopping registered outsourcing facilities from using hydroxychloroquine, although Hahn noted that there are no FDA-approved therapeutics or drugs to treat, cure or prevent COVID-19, the respiratory disease caused by the novel coronavirus.

Some FDA-approved medicines may ease COVID-19 symptoms, Hahn said. Clinical trials are under way for potential drugs and vaccines against the disease.