FDA Proposes Transition Plan for Medical Devices Granted COVID Emergency Approval
By Emma Freer

The COVID-19 public health emergency is expected to be extended a ninth time, through at least mid-July. But its eventual end raises questions about the medical devices and therapies used to diagnose and treat COVID that were issued emergency use authorizations (EUAs) on the basis of the federal emergency declaration.

Anticipating these questions, the U.S. Food and Drug Administration (FDA) has proposed giving medical device manufacturers approximately six months to secure full approval for devices issued EUAs during the public health emergency and to communicate regulatory status changes to physicians, patients, health care facilities, and others, according to a proposed transition plan issued in late December 2021.

FDA has not yet issued a proposed transition plan for COVID treatments that are still under an EUA.

Medical devices that received EUAs related to the COVID-19 pandemic include personal protective equipment, diagnostic tests, ventilators, and respirators, according to FDA. Physicians should continue to pay attention to notifications from the agency and device manufacturers as well as keep an eye out for the final transition plan.

The U.S. Department of Health and Human Services is required to provide advance notice before an EUA declaration is terminated, according to FDA.

“Given the magnitude of the COVID-19 [public health emergency], FDA recognizes that continued flexibility, while still providing the necessary oversight, will be appropriate to facilitate an orderly and transparent transition back to normal operations,” according to the proposal.

The public health emergency is slated to expire in mid-April. However, the Biden administration has said it will give states 60 days’ notice before it ends, a deadline that passed on Feb. 16.

In the meantime, FDA’s proposed guidance encourages device manufacturers that have received EUAs during the public health emergency to plan for this contingency in advance, including how they would notify physicians, patients, health care facilities, and others of any changes to a device’s regulatory status.

More insight into the FDA guidance, including hypothetical examples, can be found in the proposed transition plan, which remains subject to change.

As for COVID vaccines and treatments, the Pfizer and Moderna COVID-19 vaccines have received full approval from FDA, after initially being granted EUAs. As of this writing, the Johnson & Johnson COVID-19 vaccine and some treatments, including the monoclonal antibodies Evusheld and bebtelovimab, remain under EUAs.

 

Last Updated On

March 29, 2022

Originally Published On

March 29, 2022

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Emma Freer

Associate Editor

(512) 370-1383
 

Emma Freer is a reporter for Texas Medicine. She previously worked in local news, covering city politics, economic development, and public health. A native Clevelander, she graduated from Columbia Journalism School and the University of St. Andrews.

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