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# Russian Ventilators Entered U.S. Without FDA Oversight: Reuters
- URL: https://www.fdaweb.com/russian-ventilators-entered-u-s-without-fda-oversight-reuters/
- Published: 2020-05-27T12:00:00.000Z
- Updated: 2026-09-14T16:16:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5146866

Reuters reports exclusively that a shipment of Russian Aventa-M ventilators was negotiated by president **Donald Trump** with Russian president **Vladimir Putin** and was received by the Federal Emergency Management Agency (FEMA) 4/1 without oversight from FDA. The news service says the ventilators were sent to New York and New Jersey but were not needed and were later returned to FEMA. The devices are now being investigated in Russia for causing deaths in hospital fires.

The ventilators did not receive FDA’s expedited use authorization (EUA) before being delivered to the states, FDA told Reuters. “But the lack of FDA oversight on the Russian shipment adds to concerns about shortcuts taken by the Trump administration in responding to the pandemic,” the story says. “FDA has issued EUAs for ventilators from other sources.”

“In this case, FDA was rendered irrelevant,” said Public Citizen’s **Michael Carome**. “Here we have the wild, wild West with Trump going out and negotiating deals in other countries without coordinating with public health experts.” The news service says the White House declined to comment and referenced an earlier FEMA statement that the ventilators had not been used.

According to an FDA statement to Reuters, the ventilators were distributed under a policy that was created 3/22 and allowed ventilators to be used in the U.S. without an EUA while the agency “works interactively with the firms to get the required authorizations.” Under the policy, FDA would notify the manufacturer that it does not intend to object to the distribution “while the manufacturer is preparing, and FDA is reviewing, the EUA request.” FDA also is to ask the manufacturer to provide information ahead of distribution, including documentation showing that the device’s power supply is compatible with U.S. standards. The agency declined to tell Reuters whether it obtained such documentation for the Aventa-M.

A source described by Reuters as being close to the Russian government and aware of the situation said FDA permission may not have been required because “this cargo was a symbolic thing. It had more political than practical meaning.”