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Safety Group ECRI Reminds Hospitals That FDA’s EUA Process A ‘Lower Standard’ For Device Approvals

 
• By Sue Darcey

The nonprofit patient safety group ECRI that focuses on device safety and efficacy warns about medtech with EUAs in its “2021 Top 10 Health Technology Hazards.”

Elderly woman communicating with doctor through computer; telemedicine concept
"Rapid adoption of telehealth technologies that can leave patients and data at risk" was ECRI's third-highest hazard listed for 2021 • Source: Shutterstock

A well-known independent patient safety group, ECRI, cautions in its 28 January “hazards” report that the US Food and Drug Administration’s heavy reliance on emergency use authorizations (EUAs) for COVID-19 medical devices to fight the virus means the agency was using a “lower standard” than it usually does for medtech approvals.

ECRI added in its 2021 Top 10 Health Technology Hazards executive briefthat to control the No. 1 hazard on its list – “Complexity of managing medical devices with COVID-19 emergency...

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• By Amanda Maxwell

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• By Ashley Yeo

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Industry Execs Talk Tariff Turbulence During MD&M East

 
• By Brian Bossetta

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More from Policy & Regulation

Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

FDA Draft Guidance Introduces Electric Submission For Q-Sub Process

 
• By Brian Bossetta

The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.

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• By Brian Bossetta

During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.