MedTech Dive September 3, 2021
Marcus Schabacker contends the device approval system was already flawed before the pandemic, while noting concerns about cyberattacks and the jump in at-home care.
As the pandemic intensified in the U.S., FDA granted emergency use authorizations for a slew of medical devices to fill shortages of crucial medical supplies when hospitals began filling up with COVID-19 patients.
The special authorizations were made for devices ranging from COVID-19 tests and personal protective equipment to ventilators and remote patient monitoring devices. EUAs allow products not yet cleared or approved to be used or allow devices to be used beyond their original indication to help address the pandemic.
Marcus Schabacker, CEO of the watchdog group ECRI, said the use of EUAs can compromise...
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