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FDA Lets Some Changes To Monitoring Tools Bypass Clearance Process During COVID-19 Pandemic

 
• By Elizabeth Orr

Manufacturers can expand the remote-use capabilities of patient-monitoring devices like thermometers and stethoscopes without alerting the US FDA during the coronavirus crisis, a new guidance document from the agency says.

Remote medicine concept. Telemedicine.
• Source: Shutterstock

Manufacturers of many types of patient-monitoring devices can add or improve remote-monitoring features without first getting regulatory clearance during the COVID-19 public health crisis, the US Food and Drug Administration said in an immediately-in-effect guidance document issued on 20 March.

The move is intended to help reduce the burden the novel coronavirus places on the health care system, the guidance...

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