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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 explains. Specifically, allowing patients with other conditions to be monitored...

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