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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...

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• By Amanda Maxwell

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

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Guidance Details EU Approach On Medtech, AI Regulation Interplay

 
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UK MHRA Joins New Global Network For Safe Use Of AI In Healthcare

 
• By Natasha Barrow

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More from Policy & Regulation

Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations?

 
• By Brian Bossetta

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FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 
• By Natasha Barrow

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

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