Publication | BRG

COVID-19’s Lasting Impact on the Medical Device Regulatory Environment

Edward J. Buthusiem, Briannon Irwin, and Kylie Fultineer

April 13, 2020

Congress has initiated new efforts to address supply chain security and supply shortages of critical drugs and medical devices in response to the ongoing outbreak of the novel coronavirus (COVID-19) pandemic.

The CARES ACT will soon require medical device companies to notify the Federal Drug Administration of shortages in critical life-sustaining medical devices, bringing them on par with drug companies already subject to these reporting requirements.

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Edward J. Buthusiem

Managing Director

Washington, DC

Briannon Tunstall

Associate Director