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

20 Mar 2020

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...