HHS Waits for FDA OK as It Buys 10 Million ‘Reusable’ N95s

The Department of Health and Human Services bought 10 million “reusable” N95 respirators on condition that those masks receive emergency use authorization by the FDA, according to an HHS spokesperson.

The contract with American Medical Depot, a medical supply distributor, lists the respirators as having a 14-day reusability. However, the respirators—made by Nexera Medical—are only approved for single use by the Food and Drug Administration, American Medical President Akhil Agrawal said in an emailed statement.

A request is being submitted to the FDA for an emergency use authorization to allow the Nexera respirators to be reused, Agrawal said. The respirators have been approved for 28-day reusability in Canada and 14-day reusability in the European Union.

The respirator order is “pending submission and approval of an FDA Emergency Use Authorization and other applicable certifications,” the HHS spokesperson said.

An FDA spokesperson said they couldn’t provide specific information on the emergency use authorization submission because it is considered confidential commercial information.

“This antibacterial reusable N95 respirator is an innovative product that we feel will prove invaluable to our frontline health care workers in the fight against COVID-19,” Agrawal said. The masks will be delivered to the Strategic National Stockpile, he added.

The contract requires delivery by June 30, according to a Bloomberg Government database.