Flawed. That’s how Marcus Schabacker, CEO of ECRI, describes the device approval process for granting emergency use authorizations during the COVID-19 pandemic. And now, he says it’s time the U.S. FDA and the industry re-examine the quick process that could compromise patient safety.
“The FDA in rapid manner authorized hundreds, literally hundreds, now over 1,000, consumables and devices with EUA,” Schabacker said. “For us, that was an alarm bell because for medical devices, in particular, we don’t believe that we still have found the right approach for clearing those devices for usage.”
Schabacker added that there are already safety concerns with the primary medical device review process, the abbreviated 510(k) pathway, and EUA authorizations “shortcut the shortcut.”
While the Delta variant of the coronavirus has sparked another surge across the U.S., the CEO contends that the crisis has eased from levels seen last year and the EUA risks need to be addressed by regulators and industry.
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